QA Manager


Premium Job From Real Staffing

Recruiter

Real Staffing

Listed on

11th October 2018

Location

London

Salary/Rate

£300 - £400

Type

Contract

Start Date

ASAP

This job has now expired please search on the home page to find live IT Jobs.

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

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