 |
| Job Title |
|
Medical Device Regulatory Affairs Associate |
| Salary/rate |
|
£28000 - £35000/annum |
| Location |
|
Hertfordshire, South East |
| Job Number |
|
120249793 |
| Posted |
|
07/02/2012 (11:09) |
| Agency/Employer |
|
Quality Start |
Description
|
|
Medical Device Regulatory Affairs Associate - Hertfordshire
Opportunity:
This is a great opportunity for a Regulatory Affairs (RA) Specialist to develop their career in regulatory affairs for medical devices.
Your role as an RA Associate will be responsible for the product license transfer, manufacturing technology transfer as well as EU/ECMEA expansion of the license for medical devices mainly Class III devices.
In addition, you will be responsible for regulatory affairs facility change control of products and act as site/facility regulatory contact for Quality (Implementation Action Plans, Complaints) and R&D.
You will work on cross functional project teams and support EMEA expansion activities for the medical devices.
You will participate in product projects with responsibility for regulatory labelling requirements/aspects (reviewing and approving medical device labelling) as well as establish/maintain design dossier(s) for devices per EU requirements.
You will liaise with Notified bodies/Competent authorities as appropriate.
This is a full time permanent job opportunity you do not want to miss out on.
Skills:
To apply for role of Medical Device Regulatory Affairs Associate you will have the following:
Educated to degree level (a scientific/engineering degree).
Good regulatory affairs background ideally with medical device (or pharmaceutical) regulatory affairs experience, ideally class IIB/III medical devices.
If your experience is pharmaceutical regulatory affairs, then RAC certification is preferred.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
|
 |
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| Job Title |
|
Pharmaceutical Six Sigma Production Process Engineer |
| Salary/rate |
|
£32000 - £40000/annum |
| Location |
|
Hertfordshire, South East |
| Job Number |
|
120248990 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Pharmaceutical Six Sigma Production Process Engineer Hertfordshire
Opportunity:
This is a great opportunity for someone who has good six sigma and lean manufacturing experience to identify and manage production projects to improve process for a global pharmaceutical / medical device manufacturing company.
If you want the next career change for a company that is growing with great career prospects then this is the role for you!
Your role as a Six Sigma Production Process Engineer based in Hertfordshire will involve initiating and managing production projects to improve processes using Six Sigma and Lean techniques as well as lead all CAPA action and change control implementation projects.
Other duties and responsibilities include:
Investigation of non conformance issues, implement solutions, write up and present to QA for closure.
Lead all process improvement activities within the production department.
Manage the transfer and procurement of production equipment.
Actively participate in the creation and maintenance of Standard Operating Procedures.
Lead training activities for production processes and procedures.
Liaise with other functions to ensure the processes and procedures needed to maintain systems are established, understood and implemented.
This is a full time permanent job opportunity.
Skills:
To apply for the role of Pharmaceutical Six Sigma Production Process Engineer you will have the following:
Ideally a degree in an Engineering discipline.
Strong experience in implementing Six Sigma and Lean processes within a GMP production / manufacturing environment within the pharmaceutical or medical device industry.
Full breadth experience associated to process development and product transfer.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
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| Job Title |
|
Temporary Quality Assurance Systems Associate |
| Salary/rate |
|
£21000 - £28000/annum |
| Location |
|
Hertfordshire, South East |
| Job Number |
|
120248993 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Temporary Quality Assurance Systems Associate Hertfordshire
Opportunity:
Your role as a Quality Assurance Systems Associate based in Hertfordshire will involve developing and maintaining an effective and compliant quality system. This will be achieved through the operational execution of key elements of the quality system, including document control, quality training, change control, CAPA and customer complaints, to maintain compliance with ISO 13485 and FDA (21 CFR) part 820 requirements.
Other duties include:
Maintenance of document control system-paper and electronic.
Writing, reviewing, distributing and filing/archiving of completed quality system documents.
Handling of Change Control and CAPA processes within the Quality Systems.
Root cause investigations using various process improvement methodologies.
Complaints handling.
Auditing as well as supporting notified body and regulatory authorities inspections.
Supplier quality assurance development.
New product development and regulatory affairs.
This is a temporary 12 months role to cover maternity.
Skills:
To apply for this fantastic role of Quality Assurance Systems Associate you will have the following:
Degree or equivalent qualification in a scientific subject.
Quality assurance systems experience either in medical device, pharmaceutical or related scientific industry.
PC competent Word, Excel, Access and PowerPoint.
QA GMP Quality Systems.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
|
Contract |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
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| Job Title |
|
Analytical Quality Control Laboratory Manager |
| Salary/rate |
|
£40000 - £45000/annum |
| Location |
|
Kent, South East |
| Job Number |
|
120244659 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Analytical Quality Control Laboratory Manager ? Kent
Opportunity:
This is a great opportunity for a Quality Control / Quality Assurance Laboratory Manager with good experience of analytical / chemical analysis within the pharmaceutical industry to manage a lab for a growing pharmaceutical company.
The laboratory is responsible for the analysis of pharmaceutical raw materials, active ingredients, and finished products to ensure that they comply with internal and regulatory specifications. Chemical analysis, stability testing, protocol writing, and checking analytical data in accordance with cGMP are all within the scope of the role.
Key duties and responsibilities will include:
* Providing leadership and management within the department through a structural process of objective setting, performance appraisal, and individual development.
* Improving the overall department productivity and efficiency.
* Ensuring all QC operations are carried out in accordance to cGMP.
* Reviewing and approving analytical data & results, ensuring that they comply with internal and regulatory specifications.
* Ensuring robust training and self-inspection programs within the laboratories, as well as the review of SOPs, investigations, specifications, methods, validation reports, and cleaning verification reports.
* Implementing new procedures.
* Maintain the risk-based and scientific-based quality system as part of the Quality Unit.
* Establishing and maintaining efficient workflows to ensure operational excellence.
* Facilitation of method transfers.
This is a full time permanent job opportunity you do not want to miss out on.
Skills:
To apply for the role of Analytical Quality Control Laboratory Manager you will have the following:
* A BSc in Chemistry (or equivalent).
* Have experience in managing or supervising an analytical laboratory in a GMP environment encompassing Pharmacopoeial and in-house testing.
* Experience in stability, method validation and troubleshooting for various analytical techniques such as HPLC, GC, IR, and UV is essential.
* Empower experience would be beneficial.
Applications from Qualified Persons are welcomed in order to provide on-site coverage to the main company QP.
How to Apply:
If this sounds like the role for you or a colleague then please don?t hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
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| Job Title |
|
GCP Quality Assurance Administrator |
| Salary/rate |
|
£18000 - £20000/annum |
| Location |
|
Cambridgeshire, East Anglia |
| Job Number |
|
120246685 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
GCP Quality Assurance Administrator Cambridgeshire
Opportunity
Are you the administrator my client is looking for? Are you organised, have a good eye for detail and currently work within a quality assurance admin role within the scientific industry? If yes, then please read on.
Your role as a GCP Quality Assurance Administrator will provide administration support to the QA team who have a heavy schedule of audits for 2012 and beyond.
The role will include the following duties:
Providing support to the Clinical Quality Assurance team, such as scheduling and organising audits with the associated administration.
Updating and managing the corrective and preventative actions database arising from audits and inspections.
Managing key aspects of SOP administration for the site.
Setting up meetings and calendar appointments.
Taking and distributing minutes as required.
Supplying departmental metrics in support of Quality Review meetings.
Responding to email and telephone queries.
Archiving documentation.
Skills:
In order to apply for the GCP Quality Assurance Administrator role you will have the following skills:
Degree qualified or educated to A-Level.
Experience of Quality Assurance ideally within the pharmaceutical or related industry.
Computer literate in Microsoft Office packages including Adobe Acrobat.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
|
| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
|
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| Job Title |
|
Medical Device Design Process Quality Assurance Engineer |
| Salary/rate |
|
£35000 - £45000/annum |
| Location |
|
Hertfordshire, South East |
| Job Number |
|
120246257 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Medical Device Design Process Quality Assurance Engineer Hertfordshire
Opportunity:
This is a great opportunity for someone with good design control, risk management and process development medical device experience to join a global company with great career development.
Your role as a Medical Device Design Process Quality Assurance Engineer based in Hertfordshire will involve being responsible for the design control assurance and risk management support for the development of new products throughout the product lifecycle.
You will provide quality engineering and process excellence support for existing products covering supply chain, production and post-production processes as well as organise and facilitate continuous improvement activities to improve process efficiency, product compliance and control.
Other duties and responsibilities include:
Maintain design history files, data trending and analysis.
Define, interpret and classify critical quality characteristics for new products and processes.
Produce and maintain appropriate and comprehensive quality and control plans as required during the development and implementation of new products/technologies/processes.
Utilize best practices for experimental design, fundamentals of statistical process control, sampling rationale, and reliability assurance.
Define, identify, and apply product and process control methods e.g. control plans, identifying critical control points, developing and validating work instructions.
Participate in design and process evaluations including development of material and product specifications, test methods and risk analysis (e.g. DFMEA, PFMEA).
Provide technical assistance to carry out problem analysis/complaint investigation where necessary, e.g. CAPA & NCR investigation and closeout.
Supplier quality assurance development.
Identify and introduce suitable test and inspection methods using appropriate equipment and gauging and benchmark against best practice and relevant standards.
Identify, review and apply metrology techniques including measurement system analysis and calibration control.
Review, approve, and manage documents, e.g. validation protocols, SOPs, specifications for accuracy and completeness; generate/revise documents as needed.
This is a full time permanent role.
Skills:
To apply for the role of Medical Device Design Process Quality Assurance Engineer you will have the following:
Degree or equivalent qualification in an engineering, scientific or technical subject.
Medical device experience.
Ideally application of design control and risk management (ISO 14971) principles.
Ideally experience in developing design history files for medical devices.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
|
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| Job Title |
|
Contracts Administrator 12 Months Contract |
| Salary/rate |
|
£22000 - £25000/annum |
| Location |
|
Newbury, Berkshire |
| Job Number |
|
120246861 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Contracts Administrator 12 Months Contract - Newbury
Opportunity:
This is a great opportunity for a Contracts Administrator to join a global scientific manufacturing company on a 12 months contract to cover maternity.
Your role as a Contracts Administrator based in Newbury, Berkshire will involve preparing bids, contracts and tenders as well as manage the overall tender response process, and respond to all related internal and external enquiries.
You will support staff from various departments on all sales contracts, extensions, and terminations as well maintain a central contracts database, and support the recording of contract compliance, annual price reviews, tender submissions, contract award / decline, and debrief information.
You will receive and resolve enquiries from external and internal stakeholders regarding contracts as well as provide advice to internal stakeholders on EU Procurement Legislation and the tender process.
This is a full time 12 months contract to cover maternity. Salary is £22,000 to £25,000 per annum and a potential bonus up on completion of the full contract.
Skills:
To apply for the role of Contracts Administrator you will have the following:
Degree qualified or a minimum three A-levels at Grade A C.
Experience of sales or tender bidding processes, preferably with the NHS, pharmaceutical, healthcare, medical device or related industry.
Knowledge of EU Procurement Legislation and/or basic contract law.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
|
| Job Type |
|
Contract |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
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|
| Job Title |
|
Pharmaceutical Manufacturing Maintenance Technician |
| Salary/rate |
|
£20000 - £25000/annum |
| Location |
|
Hertfordshire, South East |
| Job Number |
|
120241758 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Pharmaceutical Manufacturing Maintenance Technician Hertfordshire
Opportunity:
Are you currently working as an Electrical Maintenance Technician within the pharmaceutical or related industry? Do you have the City and Guilds Electrical qualification? Want to develop your career for a global pharmaceutical / medical device company? Yes, then this is an opportunity you do not want to miss out on.
Your role as a Pharmaceutical Manufacturing Maintenance Technician based in Hertfordshire will involve providing both Reactive and Preventative maintenance including all HVAC Systems, Boilers, Pumps, Valves, Air Handling Units, BMS Controls, Small Power, Lighting, etc. This is a hands on role and you will provide full facilities services to internal users which will include, Mechanical, Electrical, plumbing and fabric tasks as directed by the Facilities Manager.
Other duties and responsibilities include:
Maintenance of ACOP L8 Control of Legionellosis.
Maintenance of Building Management Systems (BMS).
To have a responsibility for the Health and Safety for yourself and others.
Maintain the Permit to Work System and a LOTO System.
This is a great brand new full time permanent opportunity really suited for candidates doing a similar role who are looking for a new career move.
Skills:
To apply for the role of Pharmaceutical Manufacturing Maintenance Technician you will have the following:
Manufacturing maintenance experience ideally within the scientific production industry.
City and Guilds Electrical qualification.
Familiarity with current facility, environment and health and safety legislation.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
|
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|
|
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| Job Title |
|
Quality Assurance/Quality Control Associate GMP/GLP |
| Salary/rate |
|
£20000 - £27000/annum |
| Location |
|
Hertfordshire, South East |
| Job Number |
|
120243449 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Quality Assurance/Quality Control Associate GMP/GLP - Hertfordshire
Opportunity:
Are you currently working within quality assurance and or quality control within the medical device, pharmaceutical or related industry? Do you have a good understanding of GMP and GLP? Have you maintained quality systems? Want to work for an innovative company? Yes, then you do not want to miss out on this role.
Your role as a Quality Assurance/Quality Control Associate GMP/GLP will involve QC checking, batch and document review, support for investigations into non-conformances, CAPA's and complaints to maintain compliance with my clients quality system.
You will deal with:
* Product release.
* Goods Inwards Quality Control.
* Calibration/Maintenance Control.
* Documentation Control.
* Control of Batch Documentation.
* Quality Assurance and Quality Control.
* Auditing.
This is a full time permanent job opportunity.
Skills:
To apply for the role of Quality Assurance/Quality Control Associate GMP/GLP will have the following:
* Degree or equivalent qualification in a scientific or technological subject.
* Experience in the Quality Control and Quality Assurance of medical technology/ pharmaceuticals, or a related regulated environment.
* PC competent - Word, Excel and PowerPoint.
* QA GMP and Quality Systems experience.
How to Apply:
If this sounds like the role for you or a colleague then please don't hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
|
| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
|
|
|
|
|
|
|
| Job Title |
|
Quality Assurance Systems Associate |
| Salary/rate |
|
£25000 - £30000/annum |
| Location |
|
Hertfordshire, South East |
| Job Number |
|
120243446 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Quality Assurance Systems Associate - Hertfordshire
Opportunity:
Are you currently working in QA looking for your next career move? Do you want to work for a forward thinking company that is going from strength to strength with a family culture feel? If this is you then please read on as this is an opportunity you can't miss out on.
Your role as a Quality Assurance Systems Associate based in Hertfordshire will involve developing and maintaining an effective and compliant quality system. This will be achieved through the operational execution of key elements of the quality system, including document control, quality training, change control, CAPA and customer complaints, to maintain compliance with ISO 13485 and FDA (21 CFR) part 820 requirements.
Other duties include:
* Maintenance of document control system-paper and electronic.
* Writing, reviewing, distributing and filing/archiving of completed quality system documents.
* Handling of Change Control and CAPA processes within the Quality Systems.
* Root cause investigations using various process improvement methodologies.
* Complaints handling.
* Internal and supplier auditing as well as supporting notified body and regulatory authorities inspections.
* Supplier quality assurance development.
* Training in GMP and quality assurance.
* New product development and regulatory affairs.
There are great benefits to this role as well as a salary of £25,000 - £30,000 per annum dependent on skills and experience.
Skills:
To apply for this fantastic role of Quality Assurance Systems Associate you will have the following:
* Degree or equivalent qualification in a scientific subject.
* Quality assurance systems experience either in medical device, pharmaceutical or related scientific industry.
* PC competent - Word, Excel, Access and PowerPoint.
* QA GMP Quality Systems.
How to Apply:
If this sounds like the role for you or a colleague then please don't hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
|
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|
| Job Title |
|
Investigational Medicinal Products (IMPs) Qualified Person Manager |
| Salary/rate |
|
£40000 - £55000/annum |
| Location |
|
Nottingham, East Midlands |
| Job Number |
|
120242493 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Investigational Medicinal Products (IMPs) Qualified Person Manager Nottingham
This is a fantastic opportunity for a Qualified Person (QP) Manager to join a global leader within the pharmaceutical / clinical research industry.
Your role as a Investigational Medicinal Products (IMPs) Qualified Person Manager based in Nottingham will involve releasing manufactured, assembled and imported Investigational Medicinal Products.
Duties and responsibilities include:
Batch Review, certification and release of manufactured, assembled or imported investigational medicinal products.
Maintenance of the Product Specification File for individual studies.
Interpretation and communication of GMP regulatory requirements to staff and customers.
Guidance and mentoring to QA and Pharmaceutical Sciences staff in GMP requirements and issues.
Review and approval of pharmaceutical development protocols and reports.
Review and approval of master batch records.
Review of drug product sections of Investigational Medicinal Product Dossiers.
Review and approval of out of specification results/laboratory investigations/Quality Issues and deviations.
Involvement in study team meetings, discussions, etc as required.
Assistance with planning, conduct, reporting and follow up of GMP audits (internal and sub-contractor or supplier).
Involvement in customer, regulatory or other inspections/audits as required.
Involvement in customer meetings as required.
This is a full time permanent job opportunity paying a great salary of £40,000 - £55,000 per annum.
Skills:
To apply for the role of IMP Qualified Person Manager role you will have the following:
Eligible to act as a QP for Investigational Medicinal Products as defined by The Medicines for Human Use (Clinical Trials) Regulations 2004.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
|
| Job Type |
|
Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
|
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| Job Title |
|
Excellent Senior Regulatory Affairs Specialist Opportunity |
| Salary/rate |
|
£35000 - £40000/annum |
| Location |
|
Bradford, West Yorkshire |
| Job Number |
|
102112161 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Excellent Senior Regulatory Affairs Specialist Opportunity Bradford
Opportunity:
This is a fantastic opportunity for someone who is currently working in regulatory affairs within the agrochemicals and herbal industry to join a global leader.
Your role as a Senior Regulatory Affairs (RA) Specialist based in Bradford will involve preparing submissions to obtain and maintain registrations of the company products as required. You will be a source of expertise within the registration group for specific aspects of modelling / risk assessment and represent the company with customers and regulators as required.
Other duties and responsibilities include:
Registration submissions: prepare overviews and risk assessments as needed for completion.
Liaise with regulatory bodies, Country Agents and other appropriate resources to gather and disseminate information on regulatory requirements, including changes and threats to product listings, to ensure timely registration and protect corporate interests.
Maintain up-to-date knowledge of environmental modelling systems.
Requisition and monitor testing in support of registration submissions with internal or external suppliers.
Represent the company in meetings with customers, regulators and industry Task Force meetings at EU level.
Deputise for the Registration Manager as required.
This is a full time permanent job opportunity paying a salary of £35,000 to £40,000 per annum.
Skills:
To apply for the Senior Regulatory Affairs Specialist role you will have the following:
Graduate scientist with broad working knowledge of both chemistry and biology.
Experience with registration of products, especially agrochemicals, worldwide.
Good knowledge of risk assessments, especially environmental models.
Computer literate with good organisational skills.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
|
N/A |
| Start Date |
|
ASAP |
| Contact Details |
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| Job Title |
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Pharmaceutical Pharmacovigilance Associate |
| Salary/rate |
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£20000 - £25000/annum |
| Location |
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Cambridgeshire, East Anglia |
| Job Number |
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120246682 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
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|
Pharmaceutical Pharmacovigilance Associate Cambridgeshire
Opportunity:
Your role as a Pharmacovigilance Associate based in Cambridgeshire will involve reporting to the Pharmacovigilance Manager where you will be responsible for the data entry of adverse event case reports from post marketing and clinical trial sources onto a global safety database (ARISg), in accordance with company SOPs and regulatory requirements.
Other duties include:
Narrative writing.
Literature review.
MeDRA coding.
Using and maintaining the global safety database (ARISg).
Contributing to the ongoing enhancement of Pharmacovigilance processes and writing Standard Operating Procedures.
Supporting the Pharmacovigilance team with the creation and quality control of safety reports in CSRs, ASR/PSURs, and regulatory dossiers.
Skills:
In order to apply for the Pharmacovigilance Associate role you will have the following skills:
Life science graduate with relevant pharmacovigilance work experience.
Competent with scientific/medical terminology; good IT skills; impeccable attention to detail; report writing experience and good communication skills.
Previous use of a database (preferably ARISg web based), narrative writing, or medical writing experience would be advantageous.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
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ASAP |
| Contact Details |
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| Job Title |
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Clinical GCP Quality Assurance Manager |
| Location |
|
Cambridgeshire, East Anglia |
| Job Number |
|
120235569 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
Clinical GCP Quality Assurance Manager Cambridgeshire
Opportunity:
Your role as a Clinical GCP Quality Assurance (QA) Manager will involve managing the GCP Clinical QA Group concentrating on Phase III studies leading to US FDA NDA approval.
As a key manager within the multi-disciplined company QA team you will utilise your extensive GCP knowledge and excellent leadership and communication skills to lead the Clinical QA Audit team and oversee the design and implementation of the audit programme, including internal systems, external suppliers, documentation and international investigator site audits.
You will also provide support, advice, education and training to other departments involved in clinical trials and may become involved with cross-functional GMP and GLP audits. As part of the role, you will be tasked with organising a quality system for introducing assessments for training competency at all operational levels.
As well as having knowledge of clinical trials safety reporting requirements, you will also have experience of the commercial commitments for Pharmacovigilance for both EU and US, in order to manage quality audits for these systems in Phase IV studies and a worldwide marketplace.
You will host Regulatory Authority GCP and Pharmacovigilance inspections where required and manage the CAPA process to close out. You will give strong input into the set up and maintenance of procedures within Clinical Development departments and support the development and audit of licence application dossiers.
This is a full time permanent job opportunity and salary is negotiable for the right candidate.
Skills:
To apply for the Clinical GCP Quality Assurance Manager role you will have the following:
A Bioscience degree or nursing qualification.
Broad experience in clinical research and commercial pharmacovigilance.
Must have worked in a GCP or regulatory environment for at least eight years.
Three to five years quality assurance experience in a GCP environment.
A working knowledge of Oncology or Neuroscience would be advantageous.
Experience of successfully managing a team.
A full driving licence is required along with the ability to travel approximately 25% both within the UK and overseas.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
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ASAP |
| Contact Details |
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| Job Title |
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GMP Production Associate / Technician |
| Salary/rate |
|
£20000 - £30000/annum |
| Location |
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Hertfordshire, South East |
| Job Number |
|
120239369 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
GMP Production Associate / Technician Hertfordshire
Opportunity:
Your role as a GMP Production Technician / Associate based in Hertfordshire will involve working in a clean room manufacturing environment conducting production activities as allocated on the production planning system to cGMP and ISO standards.
You will follow written instructions with care, record activities accurately and neatly, inform the production planner if allocated tasks are not complete and adhere to good housekeeping. You will also be responsible for carrying out routine maintenance and repairs to clean room equipment.
Skills:
To apply for the role of GMP Production Technician / Associate you will have the following:
GCSE English and Maths Grade C or above.
Pharmaceutical/medical device GMP production / manufacturing / operator experience, in a clean room environment. Experience of carrying out maintenance of clean room equipment is desirable.
PC literate and numerate.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
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ASAP |
| Contact Details |
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| Job Title |
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GMP Production Team Leader |
| Salary/rate |
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£28000 - £35000/annum |
| Location |
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Hertfordshire, South East |
| Job Number |
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120239264 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
|
|
GMP Production Team Leader - Hertfordshire
Opportunity:
Calling all Production Team Leaders / Supervisors this is an opportunity you do not want to miss out on. My client is looking to recruit an experienced Production Team Leader / Supervisor ideally within the pharmaceutical / medical device or related industry to supervise the day to day production operations, ensuring that they are carried out in a cGMP and ISO13485 compliant manner, in accordance with authorised Standard Operating Procedures (SOPs).
You will manage and lead the production team, ensure that all equipment in the allocated area is maintained and calibrated as well as be responsible for deciding the work flow, hold Production Meetings, to organise the daily activities of the staff and to plan ahead for future work.
You will work to the requirements of GMP, ISO, HSE and COSHH and stand in for the Production Manager in their absence.
This is a fantastic opportunity full time permanent role working within the pharmaceutical / medical device manufacturing industry.
Skills:
To apply for the role of GMP Production Team Leader you will have the following:
HNC or Degree in Science or Engineering or at least 5 years experience within a Pharmaceutical/Medical Device Industry.
Team Leader / Supervisory experience within the pharmaceutical/medical device GMP production / manufacturing, in a clean room environment. Experience of carrying out maintenance of clean room equipment is desirable.
PC literate and numerate.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
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ASAP |
| Contact Details |
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| Job Title |
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Medical Device / Plastics / Injection Moulding Quality Engineer |
| Salary/rate |
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£35000 - £45000/annum |
| Location |
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Hertfordshire, South East |
| Job Number |
|
120240394 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
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|
Medical Device / Plastics / Injection Moulding Quality Engineer Hertfordshire
Opportunity:
Your role as a Medical Device / Plastics / Injection Moulding Quality Assurance Engineer based in Hertfordshire will involve working with the VP, Quality and QA Manager to provide a Quality Engineering capability for my client. You will establish specifications and acceptance criteria for moulded components/ packaging and supplier development activities for new and existing products, together with process improvement activities using statistical /quality tools in compliance with ISO 13485 and FDA (21 CFR) part 820 requirements.
Duties include:
Establish and maintain specifications, test methods and acceptance criteria for moulded components, and critical packaging items.
Risk management activities and the development of master quality plans.
Supplier quality development.
Auditing.
Quality assurance and change control.
Quality engineering support to new product development (NPD).
Oversee all activities related to design control and maintenance of DHFs (Design History Files) for new and existing devices. Responsible for the maintenance of the design history files.
Validating clean room equipment and process validation activities, including preparation of protocols, execution and reporting.
Continuous improvement projects.
This is a full time permanent role.
Skills:
To apply for this role you must have the following:
Degree or equivalent qualification in an engineering, scientific or technical subject.
Experience in the Quality Engineering of medical technology, plastics or injection moulding.
Experience working to ISO 13485 and FDA (21 CFR) part 820 compliant systems.
Ideally Design Control and risk management (EN ISO 14971) for Class III medical device products.
Experience with developing Design History Files for devices.
Experience in vendor audit and vendor development.
Able to review data and monitor data trends.
Investigational and problem solving skills root cause analysis.
Quality Engineering tools and concepts such as dFMEAs, pFMEAs, 8D, 5 Why, SPC, Minitab, Six Sigma, Lean etc.
GMP and Quality Systems.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
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ASAP |
| Contact Details |
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| Job Title |
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Excellent Senior Regulatory Affairs Specialist Opportunity |
| Salary/rate |
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£35000 - £40000/annum |
| Location |
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Bradford, West Yorkshire |
| Job Number |
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120242499 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
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Quality Start |
| Description
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|
Excellent Senior Regulatory Affairs Specialist Opportunity Bradford
Opportunity:
This is a fantastic opportunity for someone who is currently working in regulatory affairs within the agrochemicals and herbal industry to join a global leader.
Your role as a Senior Regulatory Affairs (RA) Specialist based in Bradford will involve preparing submissions to obtain and maintain registrations of the company products as required. You will be a source of expertise within the registration group for specific aspects of modelling / risk assessment and represent the company with customers and regulators as required.
Other duties and responsibilities include:
Registration submissions: prepare overviews and risk assessments as needed for completion.
Liaise with regulatory bodies, Country Agents and other appropriate resources to gather and disseminate information on regulatory requirements, including changes and threats to product listings, to ensure timely registration and protect corporate interests.
Maintain up-to-date knowledge of environmental modelling systems.
Requisition and monitor testing in support of registration submissions with internal or external suppliers.
Represent the company in meetings with customers, regulators and industry Task Force meetings at EU level.
Deputise for the Registration Manager as required.
This is a full time permanent job opportunity paying a salary of £35,000 to £40,000 per annum.
Skills:
To apply for the Senior Regulatory Affairs Specialist role you will have the following:
Graduate scientist with broad working knowledge of both chemistry and biology.
Experience with registration of products, especially agrochemicals, worldwide.
Good knowledge of risk assessments, especially environmental models.
Computer literate with good organisational skills.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
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ASAP |
| Contact Details |
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| Job Title |
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Great Turning CNC Setter/Operator Opportunity |
| Salary/rate |
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£25740 - £27950/annum |
| Location |
|
Basingstoke, Hampshire |
| Job Number |
|
107671432 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
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|
Great Turning CNC Setter/Operator Opportunity Basingstoke
Opportunity:
Are you currently working as a Turning CNC Setter/Operator looking for a new job? Want to work for a growing innovative manufacturing company? Yes, then please read on.
Your role as a Turning CNC Setter/Operator based in Basingstoke will involve setting and operating CNC turning machines. You will safely and efficiently set and operate Twin Spindle Twin Turret multi-axis turning centres manufacturing close tolerance prismatic parts.
Other duties include:
Deburr components.
Responsible for own quality.
Assist and support Team Shift Leader, and if required deputise in his absence.
Perform other tasks within the department.
Good workshop practice and general housekeeping required to maintain the working environment.
Assist in coaching and training of others.
This is a shift based role and the salary including shift allowance is £25,740 to £27,950 depending on experience. There are also great benefits to the role - you do not want to miss out on this opportunity!
Skills:
To apply for the role of Turning CNC Setter/Operator you will have the following:
Competent to safely and efficiently set and operate Twin Spindle Twin Turret multi-axis turning centres manufacturing close tolerance prismatic parts.
Capable of presetting tooling.
Able to read engineering drawings and understanding CMM reports.
Capable of accurately using standard manual measuring equipment.
Able to make the necessary adjustments to tool offsets to maintain parts within drawing limits.
Have a good level of manual dexterity in order to deburr machined components with hand tools.
An apprenticeship or MOD equivalent is desirable.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
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ASAP |
| Contact Details |
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| Job Title |
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Pharmaceutical GMP Quality Assurance Specialist |
| Salary/rate |
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£20000 - £25000/annum |
| Location |
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Dundee, Scotland |
| Job Number |
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120232399 |
| Posted |
|
06/02/2012 (11:34) |
| Agency/Employer |
|
Quality Start |
| Description
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|
Pharmaceutical GMP Quality Assurance Specialist Dundee
Opportunity:
This is a great opportunity for a Quality Assurance Specialist to join a global pharmaceutical manufacturing company. You will drive a quality culture throughout the site to ensure products and services meet the necessary expectations and regulatory requirements.
Day to day accountabilities and responsibilities will include:
Provide assurance that all operations, processes, and procedures are performed in compliance with applicable regulations including approved Standard Operating Procedures and GMP documentation.
Creating, monitoring and maintaining quality standards for the site consistent with the standard defined in the Quality Manual, Global SOPs and other Regulatory Authorities.
Provide support and oversee the maintenance and operations of the quality systems such as TrackWise Change Control, Deviation and CAPA.
Provide support and oversee the External and Internal Complaints systems.
Support internal and supplier audits.
Drive the quality and regulatory requirements for components (primary and secondary), including printed components.
Review data and produce review documents, such as Product Quality Reviews/Annual Quality Reviews, Customer Complaint Reviews, and Deviation Reviews.
Support Validation Activities.
Training staff and Deputise for Quality Team Leader.
This is a full time permanent job opportunity with a salary range of £20,000 - £25,000 per annum - you do not want to miss out!
Skills:
To apply for the role of Quality Assurance Specialist you will ideally have experience of carrying out the above duties within the pharmaceutical or related industry.
How to Apply:
If this sounds like the role for you or a colleague then please dont hesitate to contact us. Quality Start will offer £200 to anyone who successfully recommends a candidate who is subsequently employed by our client.
To apply for this one of opportunity, please send your CV to me now or call 0113 225 1547 for a confidential chat. For a list of our current vacancies, please visit our website.
If you do not hear from Quality Start within 2 weeks your CV has not been short listed for this role.
Quality Start are acting as a specialist recruitment consultancy for this role.
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| Job Type |
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Permanent |
| Contract Length |
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N/A |
| Start Date |
|
ASAP |
| Contact Details |
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