Job Title: Qualified Person (QP) - Cell & Gene Therapy and Vaccines
Location: Southern Germany
Industry: Pharmaceutical
Contract: 12-month
About Us:
We are a leading pharmaceutical company based in southern Germany, specialising in the development and production of Cell & Gene Therapy and vaccine products. We are seeking a Qualified Person (QP) to join our team, ensuring compliance with regulatory standards, particularly in relation to Germany Drug Law Act 15.1 batch release and quality assurance processes.
Responsibilities:
- Ensure batch release of Cell & Gene Therapy and vaccine products in compliance with Germany Drug Law Act 15.1
- Oversee the quality assurance of manufacturing processes, ensuring all batches meet GMP and regulatory standards
- Release batches for sale and distribution, ensuring compliance with both local and international regulations
- Work closely with regulatory authorities to ensure smooth audits and inspections
- Provide leadership and guidance on quality assurance, focusing on batch documentation, records, and compliance
- Ensure continuous improvement and adherence to GMP standards in all manufacturing processes
- Valid Qualified Person (QP) certification in the EU
- Extensive experience with Germany Drug Law Act 15.1 batch release requirements
Deep understanding of GMP regulations, especially as they relate to Cell & Gene Therapy and vaccines
If you are interested and feel that you are a good fit for this position, please let me know a suitable time to discuss further. Send your CV and We look forward to speaking with you!
