QA Manager/ RP

QA Manager/RP I am currently working with an exciting rapid-growth Pharmaceutical company in Surrey who are looking for a QA Manager/RP to join the team. This is an important time for the business, who is supporting the research in the battle against Covid-19. As QA Manager/RP, you will be nominated Responsible Person on the licence. Your principal purpose will be to create and maintain an effective Pharmaceutical Quality Management System ( QMS ) to support MIA 17780 and WDA 17780 and ensure compliance with EU GMP/GDP . You will also provide strategic input into the business development and new product introduction processes. QA Manager/RP Responsibilities: Manage the UK Internal Audit Programme and conduct Internal Audits Support the Third Party Audit Programme managed by the Corporate QA Department. Manage the PQR review process Host and manage any Regulatory Inspections of MIA 17780 or WDA 17780 at Zentiva UK's offices Deputise for the Head of Scientific Affairs as required Key Requirements: A degree in science (preferably a life science), with record of proven success in developing and maintaining a compliant QMS to support both a WDA(H) and MIA in the UK. Eligible to act as Qualified Person or experience in acting as a Responsible Person (preferred but not required) Additional experience in the pharmaceutical industry in a related field is a requirement, in particular a good in depth knowledge of the EU Guidelines on GMP and GDP and experience of managing a QMS. Qualified Auditor with a proven track record of auditing third parties (API, Finished Product - all dosage forms, Warehousing and Laboratories) in line with GMP and GDP. Experience of managing regulatory inspections in the UK If this QA Manager/RP role looks as though it could be the next step in your career, please get in touch as soon as possible 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 Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales