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5 jobs from The Locum Practice

The Locum Practice

          

Castle House , New Barnet , Hertfordshire , EN5 1PL


Job Title QA Administrator / PA
Salary/rate £19000 - £20000/annum
Location Oxfordshire, Oxfordshire
Job Number 126245477
Posted 23/05/2012 (16:58)
Agency/Employer The Locum Practice
DescriptionRegister your CV Purpose of the Role

• To maintain the Quality Management System of the Cherwell Campus, including ensuring all Controlled Documents (SOPs, forms, etc.) are current, in date, version controlled, in the required format and distribution of these documents is controlled and sent to the correct departments and personnel.
• Act as the administrator for the Quality Management System (currently migrating to an electronic system)
• Manage the Pest Control programme, including managing the relationship with the subcontractor, the annual schedule and follow up actions arising from visits.
• Support the Quality Management Team with Administrative task to ensure full compliance of the Quality Management System, such as filing, archiving, document control, training planning, calibration schedule, internal audit schedule, absence management, minutes taking, etc.
• Represent the quality department in various committees such as H&S and Work councils.
• Act as Personal Assistant to the Quality Assurance and Regulatory Affairs Manager and help with organising agendas, audits, travel and meetings.

Scope of the Role
General Accountabilities
• Ensure all relevant equipment/material needed for the day to day running of the Quality Departments are ordered and managed, including stationery.
• Raise Purchase Order numbers for all relevant and routine payments to subcontractors and also annual fees such as those for the MHRA/ VMD /Home Office licences
• Manage external controlled documents such as client's SOPs and Forms in compliance with Good Documentation Practices.
• Prepare and issue training certificates for all internal training delivered by the Quality Management team.

General Accountabilities

• Managing, Filing and Archiving relevant Quality documents (such as TAs, Licences, Certificates, etc.) to ensure these are kept up to date and highlight review dates to the relevant Quality Managers.
• Support the Quality Management team with the Training Programme for the Quality Department, including GDP/GMP training for all members of staff.
• Manage the document control element of the QMS, ensuring all controlled documents are up to date and available to Ensure the Pest Control Programme/Schedule is followed and up to date.
• Support the Quality Management Team with the management of the Internal Audit Schedule to ensure
this is completely in a timely manner.
• Support the Quality Management team with the calibration programme of temperature sensors and
other measuring equipment to ensure they are always on date.
• Standard Operating Procedures on date and distributed accordingly.
• Forms on date and distributed accordingly.
• Maintain local logs for relevant activities such as those mentioned in the sections above (i.e. SOP forms index, document distribution, pest control schedules, etc.)

Essential Skills

• IT Skills (Miccrosoft tools such as Word, Excel, etc.)
• Experience/Training on Good Documentation Practices.
• Diplomacy and People Skills
• Good communicator and able to manage agendas, dealing with internal and external clients
and other general PA tasks
• Admin/Organisational Skills
• Excellent Organisational Skills.
• Excellent use of Microsoft tools such as Word and Excel, including the use of graphs, pivot tables, formulas, macros, etc.

• Experience and Good understanding of Good Documentation Practices.
• IT Skills Current versions of Microsoft softwares such as Word, Excel, Outlook and Power Point.
• Organisational Skills Excellent organisational skills to ensure Good Documentation Practices, including
• Document control, filing, Managing logs and records, archiving, etc.

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Job Type Permanent
Contract Length N/A
Start Date ASAP
Contact Details Apply Now
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Job Title Computer Systems Validation Engineer
Salary/rate £35000 - £37000/annum £37,000K + 25days holiday + Pension
Location Cheshire, Cheshire
Job Number 113603627
Posted 17/05/2012 (17:23)
Agency/Employer The Locum Practice
DescriptionRegister your CV Computer Systems Validation Engineer

Job Purpose

• The Computer Systems Validation Engineer (CSVE) would provide leadership and coordination of the company’s computer systems validation projects. The candidate will have an opportunity to work with internal and external parties to produce high quality solutions to critical business and regulatory requirements. The CSVE will ensure that all Quality and Requlatory business needs and deadlines are met.

Main Accountabilities

• Accountability for the development and Validation of Computer Systems/Software Validation Procedures to ensure that current regulatory compliance and company objectives are maintained.
• Act as change owner for all GxP IT Systems, including risk identification and mitigation, responsible for tracking changes through to completion.
• Preparing and executing validation protocols, reports and effectiveness reviews
• Provide IT support and assessment for relevant quality deviations. Recommend and manage corrective and preventive actions (CAPA’s) to improve IT compliance.
• Author SOP’s and work instructions relevant to the operation, maintenance and compliance of IT systems.
• Responsible for working with IT staff to maintain the compliance of IT systems throughout the lifecycle in accordance with site policies and procedures including periodic review.
• Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle
• Validation planning
• Represent IT at internal and external audits
• Work with the QA Validation department to ensure alignment between IT compliance processes and site validation policies
• Prepare operational budget and capital expenditure budget for IT projects
• Research and implement new technologies

Experience & Qualifications

Required knowledge and qualification:
• Proven experience in Pharmaceutical, Life Science or similar environment
• Proven experience with respect to Computer Systems Validation
• An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5
• An understanding and appreciation of a Quality Management role within an IT Organisation, in particular the Software Development Life Cycle (SDLC), including System Planning, Specification, Design, Testing, and Configuration Management.
• An appreciation of Auditing IT/IS suppliers with respect to a Software Quality Management System
• Able to create and execute project work plans and revises as appropriate to meet changing needs and requirements to timelines and to budget
• An understanding of databases, e.g. Access, and spreadsheets

Required Experience:
• Knowledge of Microsoft office suite of software applications and familiarisation with mainframe accounting systems in particular SAP
• Good commercial skills
• Ability to work on own initiative and develop proactive solutions to business problems
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Job Type Permanent
Contract Length N/A
Start Date ASAP
Contact Details Apply Now
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Job Title Delivery Driver
Salary/rate £8 - £9/hour Including additional benefits
Location Hertfordshire, Hertfordshire
Job Number 120260772
Posted 15/05/2012 (17:07)
Agency/Employer The Locum Practice
DescriptionRegister your CV Summary

Our client require a Delivery Driver to join one of the UK's leading medical device manufacturer's. The company have strong relationships with their main customer group, the National Health Service (NHS), and many of the products developed by the company are used daily in hospitals across the UK and the world.We require a candidate who has UK Driving License and the flexibility to travel around the UK (From Yorkshire to the South coast)

Salary - £8.00 – 9.00 per hour

Contract - Ongoing
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Job Type Contract
Contract Length Ongoing
Start Date
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Job Title Quality Assurance Officer
Location Oxfordshire, Oxfordshire
Job Number 120260360
Posted 11/05/2012 (14:25)
Agency/Employer The Locum Practice
DescriptionRegister your CV Quality Assurance Officer

Summary

To provide Quality Assurance activities for clinical trials in managing the Quality Management Systems and supporting the UK’s growing healthcare transport operation.

Essential Duties & Responsibilities

• To manage the logistics for clinical trials to constantly improve and develop the distribution service.
• Managing the warehouse distribution and secondary packaging.
• Support and advise the QA Sector.
• Provide Quality Healthcare Management support/managing supplies.
• Comply with CAPA/GMP/GDP/company and corporate policies and internal regulatory requirements.
• Reporting of Deviations, CAPAs, Change Control and Internal audits.

Requirements

• Qualification in Auditing
• Has previous experience in clinical trials and managing supplies (ideally pharmaceutical)
• Lean principles – Six Sigma
• Comply with GMP/CAPA procedures
• Pro-active and independent

For more information contact Paul at Sensible Staffing on 02083649911.
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Job Type Contract
Contract Length 3 months (Ongoing)
Start Date
Contact Details Apply Now
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Job Title Computer Systems Validation Engineer
Salary/rate £32000 - £35000/annum 25days holiday + pension + bonus
Location Cheshire, Cheshire
Job Number 113600451
Posted 03/05/2012 (17:43)
Agency/Employer The Locum Practice
DescriptionRegister your CV Computer Systems Validation Engineer

Job Purpose

• The Computer Systems Validation Engineer (CSVE) would provide leadership and coordination of the company’s computer systems validation projects. The candidate will have an opportunity to work with internal and external parties to produce high quality solutions to critical business and regulatory requirements. The CSVE will ensure that all Quality and Requlatory business needs and deadlines are met.

Main Accountabilities

• Accountability for the development and Validation of Computer Systems/Software Validation Procedures to ensure that current regulatory compliance and company objectives are maintained.
• Act as change owner for all GxP IT Systems, including risk identification and mitigation, responsible for tracking changes through to completion.
• Preparing and executing validation protocols, reports and effectiveness reviews
• Provide IT support and assessment for relevant quality deviations. Recommend and manage corrective and preventive actions (CAPA’s) to improve IT compliance.
• Author SOP’s and work instructions relevant to the operation, maintenance and compliance of IT systems.
• Responsible for working with IT staff to maintain the compliance of IT systems throughout the lifecycle in accordance with site policies and procedures including periodic review.
• Ensure that proper CSV procedures are followed during system implementations and provide CSV support for new IT projects throughout the project lifecycle
• Validation planning
• Represent IT at internal and external audits
• Work with the QA Validation department to ensure alignment between IT compliance processes and site validation policies
• Prepare operational budget and capital expenditure budget for IT projects
• Research and implement new technologies

Experience & Qualifications

Required knowledge and qualification:
• Proven experience in Pharmaceutical, Life Science or similar environment
• Proven experience with respect to Computer Systems Validation
• An understanding of Electronic Records and Electronic Signatures, e.g. USA 21 CFR Part 11, EU GMP Guidelines, Chapter 4, Annex 11 and GAMP 5
• An understanding and appreciation of a Quality Management role within an IT Organisation, in particular the Software Development Life Cycle (SDLC), including System Planning, Specification, Design, Testing, and Configuration Management.
• An appreciation of Auditing IT/IS suppliers with respect to a Software Quality Management System
• Able to create and execute project work plans and revises as appropriate to meet changing needs and requirements to timelines and to budget
• An understanding of databases, e.g. Access, and spreadsheets

Required Experience:
• Knowledge of Microsoft office suite of software applications and familiarisation with mainframe accounting systems in particular SAP
• Good commercial skills
• Ability to work on own initiative and develop proactive solutions to business problems

More
Job Type Permanent
Contract Length N/A
Start Date
Contact Details Apply Now
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5 jobs from The Locum Practice