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Interim QA Officer/Manager

Location: OXFORD, OXFORDSHIRE Salary: 28000.00 - 47000.00 GBP Per Annum
Sector: Scientific Job Type: Permanent
Shift Type: N/A Applications: N/A
Posted: about 16 hours ago Reference: 3107232
Reed Scientific are currently recruiting for an Interim Quality Assurance Manager for a world renowned organisation based in the Oxfordshire area. You will play an important role within the companies QA department and help support all QA activity for projects.

This role is initially a 6 month contract but has a good chance to extend.
My client is looking for a qualified QA Office or Manager with experience working in MHRA and FDA. Supplier audit experience is a preferable.

Responsibilities


• Ensuring all policies and procedures are robust and effectively implemented in line with both the quality systems of the unit and current legislation and guidance.

• Reporting compliance status of the facility to the license holder and the Qualified Person.

• Management of all QA activities and line management of QA staff.

• Leading the preparation of reports of the quality system status for senior management review and providing ideas and strategic guidance for continuous improvement of the quality system.

• Responsible for management and day-to-day operation of the quality system. Liaise with the company representative and Qualified Person to define overall policy and objectives.

• Suggesting solutions on ways to meet legal requirements within the constraints of an academic setting, and provide QA review and approval for validation plans, protocols and reports.

• Acting as releasing officer for release of unlicensed medicinal products (“specials”) where trained and deemed competent.

• Acting as QP delegate for routine duties for investigational medicinal products.

• Responsible for managing and implementing the facility’s audit programme.

• Taking a lead for training and developing PROx staff in GMP and relevant legislation and guidance. Taking responsibility to ensure that the evolving regulatory requirements are continuously implemented. Providing strategic guidance to the production and QC departments on how to implement quality requirements.

• Nominated host for inspections from external regulatory bodies and clients.

• Preparing or approving SOPs and work instructions and ensuring that documentation is effectively implemented, monitoring compliance with established procedures and practices.



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