Quality Start |
| Contact |
Selina Thompson |
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| Telephone |
0113 225 1547 |
| Email |
selina@qualitystart.co.uk |
| Website |
http://www.qualitystart.co.uk |
| Address |
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| Description |
Quality Start are global recruitment consultants and headhunters specialising within the Aerospace, Automotive, Banking and Financial Services, Customer Services, Defence, Electronics, Engineering, FMCG, Food, IT, Manufacturing, Oil and Gas, Pharmaceutical, Medical, Biotech, Clinical Research, Rail, Sales and Telecommunications industries.
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| Job Title |
Senior Process Development Scientist (Cell Culture) Edinburgh |
| Salary/rate |
£20000 - £30000/annum Salary is pro-rated |
| Location |
Edinburgh, Scotland |
| Job Number |
120172254 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
Description
|
Senior Process Development Scientist (Cell Culture) Edinburgh
Your role as a Senior Process Development Scientist (Cell Culture) will be responsible for leading the management and delivery of a variety of GMP process development projects to quality, time and cost standards. You will provide support to the technical teams in execution of projects and liaise with the sales team in the development of new project definition and contract.
You will act as the primary technical contact with clients and as a conduit for project technical and timeline information. You will establish and maintain a positive relationship with clients and colleagues to ensure that projects run smoothly.
Other duties include:
Transfer of projects from GMP process development to GMP manufacturing.
Process development and management.
Equipment calibration and maintenance.
Deviations management.
Project management.
Team management.
Client liaison.
Work to GMP, GLP and COSH standards.
This role is initially for 6 months which could go permanent.
To apply for the Senior Process Development Scientist (Cell Culture) role you will have the following:
Essential
BSc/HND degree in Life Science or Biological Science discipline or 3-5 years relevant practical experience.
3-5 years experience in Mammalian Cell Culture.
Knowledge of word processing, spreadsheet and database entry skills.
Desirable
PhD in relevant Science discipline or 3-5 years relevant practical experience
Understanding and experience in Stem Cells Culture.
Understanding and Experience of bacterial fermentation or Mammalian bioreactor vessels.
Understanding/knowledge of DSP.
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 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 |
6 months |
| Start Date |
ASAP |
| Contact Details |
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| Job Title |
Senior Analytical Laboratory Analyst GMP/GLP Hertfordshire |
| Salary/rate |
£26000 - £30000/annum |
| Location |
Elstree, Hertfordshire |
| Job Number |
120166714 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
|
Senior Analytical Laboratory Analyst GMP/GLP Hertfordshire
Your role as a Senior Analytical Laboratory Analyst GMP/GLP will involve performing routine laboratory sampling and analytical work in support of production, validation and new product development projects.
You will be responsible for the effective running of the analytical instruments to provide a service to multiple departments as well as calibration and maintenance of lab equipment.
Other duties include:
Analytical test method development.
Analytical test method validation.
Collecting, logging and analysing samples of in-process and finished product samples as required by the production, validation and product development teams.
Establishing and maintaining an analytical sample archiving system.
Reporting results to the validation and product development teams.
Report writing of experimental work.
Trending of production data where required.
To apply for the Senior Analytical Laboratory Analyst GMP/GLP role you will have the following skills:
A-level qualification in scientific subjects.
General laboratory analytical work.
Working with hazardous chemicals.
Working in a cGLP/cGMP environment.
Report writing of experimental work.
Experience in managing analytical equipment procurement, maintenance, and calibration.
Analytical method development.
Highly numerate and literate.
Strong IT skills.
Good record keeping skills.
Good working knowledge of laboratory health and safety procedures including COSHH.
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 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 |
Process Development Scientist Edinburgh |
| Salary/rate |
£15000 - £20000/annum Salary is pro-rated |
| Location |
Edinburgh, Scotland |
| Job Number |
120172258 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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Process Development Scientist Edinburgh
Your role as a Process Development Scientist will be responsible for ensuring the contract manufacture of products are to relevant GMP standards.
You will assist in the technical transfer of projects between Development and Production. You will establish and maintain a positive relationship with the client and colleagues to ensure that projects run smoothly.
Other duties include:
Perform activities related to the contract manufacture of Investigational Medicinal Products.
Monitor the plant and equipment to ensure continued calibration and maintenance.
Being part of the technical transfer of projects from Development to Engineering and GMP manufacturing.
Downstream processing.
Process development and validation.
Equipment calibration and maintenance.
Work to GMP, GLP and COSH standards.
This role is initially for 6 months which could go permanent.
To apply for the Process Development Scientist role you will have the following:
Essential
BSc/HND degree in relevant discipline or 2-3 years relevant practical experience.
2 years experience in downstream processing.
Knowledge of word processing, spreadsheet and database entry skills.
Desirable
Experience in protein purification and scale-up.
Experience in developing/performing analytical protein assays e.g. SDS-PAGE; ELISA; HPLC.
Understanding/knowledge of DSP,
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 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 |
6 months |
| Start Date |
ASAP |
| Contact Details |
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| Job Title |
Senior Manufacturing Scientist (Cell Culture) Edinburgh |
| Salary/rate |
£20000 - £30000/annum Salary is pro-rated |
| Location |
Edinburgh, Scotland |
| Job Number |
120172256 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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Senior Manufacturing Scientist (Cell Culture) Edinburgh
Your role as a Senior Manufacturing Scientist is responsible for ensuring the contract manufacture of IMP/APIs to GMP standards. You will perform activities to maintain GMP compliance and assist in the effective technical transfer of projects from Process Development Facilities to client facilities, and other GMP Production facilities.
You will establish and maintain a positive relationship with the client and colleagues to ensure that projects run smoothly.
Other duties include:
Perform activities related to the contract manufacture of Investigational Medicinal Products.
Transfer of projects from Development to GMP manufacturing.
Process development and management.
Equipment calibration and maintenance.
Deviations management.
Project management.
Team management.
Client liaison.
Work to GMP, GLP and COSH standards.
This role is initially a 6 months contract role which could go permanent.
To apply for the Senior Manufacturing Scientist (Cell Culture) role you will have the following:
Essential
BSc/HND degree in Life Science or Biological Science discipline or 3-5 years relevant practical experience.
3-5 years experience in Mammalian Cell Culture.
Knowledge of word processing, spread Sheet and database entry skills.
Desirable
Understanding and experience in Stem Cells Culture.
Understanding and experience of bacterial Fermentation or Mammalian bioreactor vessels.
Understanding/knowledge of DSP
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 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 |
6 months |
| Start Date |
ASAP |
| Contact Details |
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| Job Title |
IMP Qualified Person (QP) Quality Assurance Manager - North East |
| Salary/rate |
£45000 - £55000/annum |
| Location |
North East, North East |
| Job Number |
120173838 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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IMP Qualified Person (QP) Quality Assurance Manager - North East
Your role as a IMP QP Quality Assurance Manager will involve:
All QA support to clinical trial manufacturing, packaging and distribution business.
All QA support to pharmaceutical development service.
All EU importation services including pharmacovigilance.
IMP QP release.
Stand-in for the Quality Director when not on site.
To apply for this role you will be a QP for IMP however commercial QPs are also encouraged to apply for this role. Those who will be taking the Viva exam within 3-6 months can also apply for this role. You will have strong auditing skills with MHRA/FDA experience.
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 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 Quality Assurance Qualified Person Manager London |
| Salary/rate |
£55000 - £60000/annum |
| Location |
London, South East |
| Job Number |
120177920 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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Pharmaceutical Quality Assurance Qualified Person Manager London
Opportunity:
Your role as a Quality Assurance (QA) and Qualified Person (QP) Manager based in London will involve managing the quality function ensuring that all company products are generated according to Product Licenses following GMP guidelines and EEC directives.
Duties include:
Authorize specifications, sampling instructions, test methods, QC procedures and assess production documents and amendments.
Agree or decline starting materials, packaging components, intermediate bulk and finished products and appraise all completed manufacturing documents following directives and marketing authorization.
Act as Qualified Person in approving finished products for commercial release.
Observe suppliers of raw materials packaging components, maintain a high standard QC laboratory and equipment and organize the validation of analytical methods.
Recruitment and training.
Investigate all quality complaints according to written procedures and take action as necessary.
Gain authorization from the MHRA for variations and amendments which alter the manufacturing or product licenses.
Carry out a "self inspection" program and create company hygiene procedures.
Skills:
To apply for the QA/QP Manager role you will have the following skills:
You must be a Qualified Person.
GMP and EEC directive experience.
Management experience.
You will organized, motivated, dedicated and efficient with excellent written and communication 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 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 |
Manufacturing Process Development Manager GMP Hertfordshire |
| Salary/rate |
£40000 - £55000/annum |
| Location |
Hertofrdshire, South East |
| Job Number |
120175020 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
|
Manufacturing Process Development Manager GMP Hertfordshire
Your role as a Manufacturing Process Development Manager GMP will involve managing the activities of the Product Development Function and provide a world class process development function for my client.
You will devise new processes or refine existing ones to optimise the manufacturing process as well as validate new processes and revalidation of current processes.
You will develop process understanding to improve process robustness, yields and throughput by investigating process parameters to fully determine the operating envelope and provide technical support to the operation staff.
You will plan, execute and supervise process trials, monitor production process performance and support the Supply Chain function with technical assistance for supplier evaluation and raw material/component change.
Other duties include:
Department management.
Auditing.
Write protocols and reports for validation and test programmes.
Write monthly summaries of the functional activities.
New product development projects.
To apply for the Manufacturing Process Development Manager GMP role you must have the following:
Degree in Chemistry or related subject with high level of Chemistry content.
Management of a process development operation within a pharmaceutical or medical device industry, particularly identifying underlying causes of reduced yield.
Planning, managing and executing new process and process improvement projects.
Using six sigma/lean techniques to reduce process variation.
Using DoE to identify process windows.
Technical transfer of new products into production.
Working in a clean room environment sterile/ aseptic manufacturing.
Managing CAPA investigations, and the timely completion of actions.
Managing change within a regulated organisation.
Working in a fast paced, rapidly changing organisation.
Strong Excel skills and highly numerate.
Driving Licence.
ISO9001:2000 and GMP.
A change agent and resilient.
Prepared to work away from base.
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 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 |
Research & Development New Product Development Administrator |
| Salary/rate |
£25000 - £30000/annum |
| Location |
Hertfordshire, South East |
| Job Number |
120175640 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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Research & Development New Product Development Administrator Hertfordshire
Opportunity:
Your role as a Research & Development New Product Development Administrator based in Hertfordshire where you will support R&D, Project Management, Regulatory Affairs on new product development (NPD) projects.
Duties include:
Preparing, compiling and controlling of design documentation, including design history files; safety risk analyses; and regulatory technical files.
Scheduling project team meetings and taking minutes.
Preparing, publication and filing of scientific or technical reports.
Establishing a new technical report database for sharing of information across departments.
Ensuring departmental compliance with internal development procedures and applicable sections of the FDAs quality management systems.
Coordinating and assisting in the flow of samples and documentation to contract test labs and other organizations.
Working to GMP and GLP standards.
Documentation archiving.
Skills:
To apply for the role of Research & Development New Product Development Administrator role you will have the following:
Good computer skills to include Microsoft Word, Excel, PowerPoint, and Acrobat.
Min 5 years secretarial/administration experience in FDA/CE regulated R&D environment. Used to working with multi-disciplinary teams.
Good organizational abilities and excellent attention to detail.
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 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 |
Quality Assurance Manager Precision Presswork Birmingham |
| Salary/rate |
£35000 - £40000/annum |
| Location |
Birmingham, West Midlands |
| Job Number |
117156075 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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Quality Assurance Manager Precision Presswork Birmingham
Opportunity:
Your role as a Quality Assurance Manager Precision Presswork based in Birmingham will involve managing the QA function to eliminate problems and to implement a Continuous Improvement ethic across the organization.
Duties include:
Dealing with customer enquiries, complaints and returns.
Implementing and managing Continuous Improvement projects.
Management of the ISO 9001 and TS 16949 systems, along with the IMS system incorporating ISO 14001 Environmental and OHSAS 18001 Health & Safety audit systems.
Internal and supplier auditing.
Supplier quality assurance.
Ensuring compliance with national and international standards and legislation.
Setting up and maintaining controls and documentation.
Identifying relevant quality-related training needs.
Writing technical and management system reports.
Promoting and Championing change.
Skills:
In order to apply for the role of Quality Assurance Manager Precision Presswork you will have the following skills:
HND or equivalent in a Quality Management/ Manufacturing Engineering related discipline.
Experience of high volume, precision presswork.
Progression Press Tooling knowledge and experience.
IMS experience.
ISO Audit experience managing and auditing.
People Management - valid team management experience.
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 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 |
Inspector / Expediting Engineering Project Co-ordinator Aberdeen |
| Salary/rate |
£20000 - £30000/annum |
| Location |
Aberdeen, Scotland |
| Job Number |
107501782 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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Inspector / Expediting Engineering Project Co-ordinator Aberdeen
Opportunity:
Your role as an Inspector / Expediting Engineering Project Co-ordinator based in Aberdeen will involve the receipt and review of assignments from clients, identifying, sourcing and mobilisation of field engineers, issuing assignments and reviewing technical reports.
Other duties include:
Expediting all materials and equipment purchased for the project, including:
Forecasting and advising the required levels of expediting and the associated staffing requirements for the project.
Recommending purchase orders for field.
Expediting and/or coordinating the flow of engineering data between Supplier and the company.
Assist field personnel in resolution of material deficiencies after receipt.
This role is ideal for candidates looking to either progress within the Oil and Gas sector or move into the Inspection field.
Reporting to the Operations Manager you will receive training on bespoke in house systems as well as a background in the technical elements of this role.
Skills
To apply for the Inspector / Expediting Engineering Project Co-ordinator you will be a proven self-starter with enthusiasm and enjoy working using both your own initiative and as part of a small highly focused team.
You will have strong interpersonal skills, be organised and effective in managing your time and have a full understanding of Microsoft Office.
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 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 |
Pharmaceuticals Regulatory Affairs Manager Croydon |
| Salary/rate |
£40000 - £60000/annum |
| Location |
Croydon, South East |
| Job Number |
120180026 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
|
Pharmaceuticals Regulatory Affairs Manager Croydon
Opportunity:
Your role as a Pharmaceuticals Regulatory Affairs Manager based in Croydon will involve managing the regulatory affairs department ensuring timely submission of applications and negotiate favourable approvals.
You will provide regulatory and technical advice and support: actively participate in project team meetings.
Other duties include:
Ensure that the Companys activities comply with the appropriate regulatory guidelines and standards, pre-empting potential issues and suggesting possible solutions.
Prepare and review CMC elements of regulatory documentation.
Ensuring Regulatory Compliance and Good Regulatory Practice throughout the Regulatory Team and resolving regulatory problems arising to achieve a satisfactory outcome.
Overall responsibility for regulatory documentation to ensure that a reliable, accurate and easily retrievable system is maintained.
Ensuring that adequate regulatory systems and procedures are in place and are adhered to.
Regular training of staff on SOPs and company procedures.
Ensuring that regulatory documentation is safely stored, up to date and easily and completely retrievable in accordance with current standards.
Skills:
In order to apply for the Pharmaceuticals Regulatory Affairs Manager role you will have the following:
A minimum of 5 years regulatory experience with a strong technical and management background.
Bachelors degree in Pharmacy or Life Science.
Knowledge and experience of dealing with CMC data.
Knowledge of MS Word, Excel, Adobe Acrobat, Powerpoint and web surfing and regulatory document management systems e.g. Documentum.
Knowledge of European Regulations, guidelines and application procedures.
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 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 |
Pharmaceuticals Senior Regulatory Affairs Executive Croydon |
| Salary/rate |
£30000 - £40000/annum |
| Location |
Croydon, South East |
| Job Number |
120180028 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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Pharmaceuticals Senior Regulatory Affairs Executive Croydon
Opportunity:
Your role as a Pharmaceuticals Senior Regulatory Affairs Executive based in Croydon will involve:
Ensure timely submission of applications and negotiate favourable approvals.
Provide regulatory and technical advice and support: actively participate in project team meetings.
Ensure that the Companys activities comply with the appropriate regulatory guidelines and standards.
Prepare and review CMC elements of regulatory documentation.
Ensuring Regulatory Compliance and Good Regulatory Practice throughout the Regulatory Team and resolving regulatory problems arising to achieve a satisfactory outcome.
Regulatory documentation to ensure that a reliable, accurate and easily retrievable system is maintained.
Ensuring that regulatory documentation is safely stored, up to date and easily and completely retrievable in accordance with current standards.
Skills:
In order to apply for the Pharmaceuticals Senior Regulatory Affairs Executive role you will have the following skills:
A minimum of 3 years regulatory experience with a strong technical background.
Bachelors degree in Pharmacy or Life Science.
Knowledge and experience of dealing with CMC data.
Knowledge of MS Word, Excel, Adobe Acrobat, power point and web surfing and regulatory document management systems e.g. Documentum.
Knowledge of European Regulations, guidelines and application procedures.
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 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 |
Clinical GCP Quality Assurance Manager Cambridgeshire |
| Location |
Cambridgeshire, East Anglia |
| Job Number |
120181902 |
| Posted |
15/03/2010 (11:16) |
| Agency/Employer |
Quality Start |
| Description
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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 will be a broad based position, providing exposure to all aspects of drug development.
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 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 |
Fantastic Regulatory Affairs (RA) Associate Renfrewshire |
| Location |
Renfrewshire, Scotland |
| Job Number |
120182918 |
| Posted |
10/03/2010 (14:26) |
| Agency/Employer |
Quality Start |
| Description
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Fantastic Regulatory Affairs (RA) Associate Renfrewshire
Opportunity:
Your role as a Regulatory Affairs Associate based in Renfrewshire will involve:
Participation in post-market surveillance activities.
Preparation of post-market databases and reports.
Preparation of associated regulatory submission documentation.
Skills:
In order to apply for the Regulatory Affairs Associate you will have the following:
Educated to degree level.
Regulatory experience within a medical device environment is desirable.
Excellent attention to detail.
Experience of Microsoft Word and Excel.
Good communication skills, be a team-player and have a meticulous approach to your work.
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 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 |
Process Validation Quality Assurance Associate Renfrewshire |
| Location |
Renfrewshire, Scotland |
| Job Number |
120182917 |
| Posted |
10/03/2010 (14:24) |
| Agency/Employer |
Quality Start |
| Description
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Process Validation Quality Assurance Associate Renfrewshire
Opportunity:
Your role as a Process Validation Quality Assurance Associate based in Renfrewshire will involve working in the QA/QC department where you be involved in general laboratory duties, physical testing, process validation/monitoring and report writing.
You will be part of a team responsible for the installation/operational/performance qualification of lab/production equipment and write or formalise validation protocols, follow through the validation procedure and write validation reports.
This is a 6 months contract role and the salary on offer will be pro-rated.
Skills:
In order to apply for the Process Validation Quality Assurance Associate role you will have the following:
Previous experience in process validation ideally within the medical device / pharmaceutical industry.
Good interpersonal skills, attention to detail and organisational abilities.
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 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 |
6 Months Contract |
| Start Date |
ASAP |
| Contact Details |
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| Job Title |
Formulation Development Technician GMP/GLP South East |
| Location |
Kent, South East |
| Job Number |
120182895 |
| Posted |
10/03/2010 (11:38) |
| Agency/Employer |
Quality Start |
| Description
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Formulation Development Technician GMP/GLP South East
Opportunity:
Your role as a Formulation Development Technician GMP/GLP will involve developing a range of dosage forms from pre-formulation to commercialisation. This includes experimental development of new formulations, manufacture of clinical trial supplies, stability evaluations, compilation of regulatory information and technology transfer to full scale manufacture.
You will be working with cross functional departments so good time keeping and self-motivation is essential as it is often necessary to work to tight timelines.
Salary is negotiable - dependent on skills and experience.
Skills:
To apply for the Formulation Development Technician GMP/GLP role you will have the following:
A BSc degree or equivalent in a relevant science.
Good communication skills (both verbal and written).
Basic computer skills (i.e. Microsoft Word and Excel).
High attention to detail.
Experience in formulation development and GMP/GLP would be 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 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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