QA Biologics Manager
CK Group are recruiting for a QA Biologics Manager to join a drug discovery business at their site based in Slough on a contract basis initially for 12 months.
The Company: Our client is in the business of improving the lives of patients around the globe with a particular focus on neurology and immunology-based diseases.
Location: This position will be based on our client's site in Slough.
QA Biologics Manager Role: You will be responsible for providing advice and support on operational and general QA activities to other departmental teams working on Drug Substance (DS) and Drug Product (DP) Development, Technology Transfer, Manufacture and Submission Preparation.
Your main duties will be:
- Review and approval of project documentation, including technology transfer, analytical testing, analytical validation, quality agreements and batch records.
- Working closely with operational teams advising on QA compliance.
- Investigating and implementing deviations, Change Controls and CAPAs.
Your Background: The ideal candidate for this role will have the following qualifications, experience and knowledge:
- Experience quality professional who has operated in within GMP regulated environments.
- Knowledgeable in the interpretation and application of regulations combined with quality principles and techniques.
- Experienced in one or more of the following: Regulatory submission preparation for biological products, ICH Q2 analytical method validation principles, GMP process validation, Drug Substance or Drup Product process manufacture for biological products.
Apply: For more information or to apply for this QA Biologics Manager position, please contact Graeme Pallas at CK Group on 0191 384 8906 or email email@example.com, quoting job ref 48544.
It is essential that applicants hold entitlement to work in the UK.