Description
QP Batch ReleaseOur global pharmaceutical client is looking for temporary QP support. This is a hands on QP role with team management responsibilities.
Tasks and Duties:
- Release of Batches as a QP according to the German Drug Law (§ 15 AMG) in accordance with the international and national guidelines, especially with the AMG and the AMWVH.
- Review of Change Controls, Deviations,OOS investigations.
- Issue, Review and Approval of SOPs specific to their function.
- Issue of the Product Quality review.
- Management of the batch release group.
- Support and share knowledge with the batch release group, provide coaching in all related fields.
Profile:
- QP qualifications and previous experience of batch release of biotech products, ideally vaccines.
- Knowledge of FDA and EU regulatory requirements for biologics and pharmaceuticals including the German Drug Law (§ 15 AMG).
- Previous experience of Change Controls, Deviation and OOS managment.
- GMP knowledge and demonstrated ability to establish standards in support of the quality system.
- Strong analytical and problem solving skills with an ability to prioritise and manage multiple projects / tasks.
- Excellent communication, interpersonal and training skills as well as organizational skills and attention to detail.
- Business fluent in German and English.