Description
QP Batch ReleaseOur global pharmaceutical contract manufacturing client is looking for a temporary QP support. This is a hands-on QP role for preparation of batch release documentation.
Tasks and Duties:
- Release of Batches as a QP according to the French Drug Law, in accordance with the international and national guidelines.
- Review of Change Controls, Deviations and OOS investigations.
- Issue, Review and Approval of SOPs specific to their function.
- Issue of the Product Quality review.
- Support and share knowledge with the batch release group.
Profile:
- QP qualifications and previous experience of batch release of pharmaceutical products, ideally liquids and solids.
- OR strong experience in QA documentation with previous experience of preparation of QA documentation of batch release by a QP.
- Excellent knowledge of FDA and EU regulatory requirements for pharmaceuticals.
- Previous experience of Change Controls, Deviation and OOS management.
- Strong analytical and problem solving skills with an ability to prioritise and manage multiple projects / tasks.
- Excellent communication, interpersonal and organizational skills, as well as attention to detail.
- Business fluent in French and English.