CK Group are recruiting for a highly experienced QA Manager to join an innovative biotech company. This will be an office based role in Oxford on a permanent basis with flexibility of home working. This role would be ideal for a candidate with strong expertise in QMS within a GMP regulated environment.
Excellent opportunity to join a small biotech with a focus in oncology.
- Provide operational support including maintenance of the GMP quality systems, both internal and through third parties, and to be a key member of the Quality Management Team.
- provide support to the Quality Team Leadership across a broad range of responsibilities, including:
- Quality Management Systems (QMS) - contribute to the development and maintenance of QMS
- Quality Assurance and Quality Control - develop and review quality project plans ensuring they run to schedule
- Third Party Quality Assurance - support appropriate vendor selection and supplier qualification
- Minimum BSc in a Chemistry, Biology, Pharmacy or related life science.
- Experience in a GMP environment and managing GMP compliance activities.
- GMP auditing experience.
- Demonstrable experience in contributing to all clinical quality matters leading to regulatory submission, clinical protocols, conduct of clinical trials, according to all regulatory and GMP standards.
- Experience of International GMP/ICH and clinical quality laws, regulations and guidelines.
- Extensive experience in QMS and risk-based auditing within a pharmaceutical manufacturing organisation including experience in conducting an on-site audit of a vendor and clinical trial site.
- Proven experience in GMP auditing associated with chemical API and excipient manufacturers and suppliers; packaging suppliers; and solid oral dosage form manufacturers
- Experience providing internal consultation and training on quality systems and GCP.
For more information or to apply for this position, please contact Naynesh Mistry on 01246 457703 or via email on firstname.lastname@example.org, quoting job ref 52331.
It is essential that applicants hold entitlement to work in the UK.