QA Manager
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Real Staffing has partnered with a leading organisation, specialising in cell therapy products.
Due to an increase in work demand and exciting pipeline, our client is currently seeking a QA Manager, on an initial temporary contract, leading to a permanent position, for their gene therapy production facility.
This is an exciting role for someone to take on a breadth of responsibility and act as the key point of contact for a well-recognised gene therapy production facility.
Role responsibilities:
* To support the HOQ to ensure continuous improvement of the quality system
* Perform routine and oversee the day to day QA activities
* Ensure manufacturing and Quality Control (QC) testing is performed to GMP and HTA regulations
* Write, review and approve quality documentation
* Management of QMS - CAPAs, change controls and deviations
* Lead and direct the QA team
* Act as a key point of contact for regulatory inspections
* Conduct internal/external audits
* Review batch documentation for IMPs and ATMPs
* Aseptic techniques
* Equipment validation (IQ/OQ/PQ)
* Liaise and advise senior management and collaborators on QA activities.
The ideal person will need:
* A BSc (or equivalent) in a life sciences subject
* Excellent knowledge of QA within gene therapy and IMP/ATMPs
* EU GMP / HTA regulations knowledge
* QMS management experience
* Equipment validation (highly desirable)
* Experience in mentoring/training/supervising members within a QA team
To find out more about Real please visit www.realstaffing.com
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Business in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales