We have an interesting opportunity for a Senior QA Manager Drug Substance (GMP/GDP) to join a pharmaceutical company in Basel. The position is offered on a contract basis of 6 to 12 months, with a high likeliness of extension.
The successful candidate will provide GMP/GDP expertise thus ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards. Along with providing relevant expertise additional responsibilities include:
- Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
- Prepare of GMP/GDP Agreements in collaboration with CMOs and the CMC team
- Execute QA activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls.