Qualified Person / QA Manager, Frankfurt
Jim Gleeson is recruiting for a Qualified Person / QA Manager to join a global clinical trial supplies logistics organisation, based at their site in Frankfurt.
Base salary around €135K.
As Qualified Person / QAManager you will be responsible for the quality aspects of IMPs requiring importation into the EU, QP confirmation or QP certification for release into the EU. You will also have responsibility for the quality testing and approval of incoming secondary packaging materials, incoming IMPs, Marketed Product, Products for Named Patient Programs and finished product from internal packaging operations.
Key duties will include:
- Ensuring that all activities (storage, additional labelling, quality control, distribution, returns, rejects and destruction) related to IMPs, medicinal products used in clinical trials / NPPs and starting materials are performed in compliance with European and regional regulations and Good Manufacturing/Distribution Practices, as needed.
- Hosting client audits and regulatory inspections and managing the audit report responses.
- Implementation and maintenance an efficient system, handling documentation relating to Quality such as Procedures, Product Specification Files, Technical Agreements, Qualifications, Quality Systems etc
- Management of CAPA plans, collating CAPA data, and implementation of quality improvement initiatives.
- Taking responsibility for and fulfilling the role of Head of Quality Control ('Leitung der Qualitätskontrolle') for the Frankfurt depot as per current German GMP guidance AMWHV.
As Qualified Person / QA Manager you will require:
- A relevant science degree
- Qualified Person status
- Extensive pharmaceutical industry based experienced of GDP, GMP and GCP regulations
- Proven problem solving, collaboration, negotiation, and conflict resolution skills
- Ability to travel as necessary
Entitlement to work in the Germany is essential. For more information please contact Jim Gleeson on +44 (0)1438 842973 or email firstname.lastname@example.org. Please quote reference 49621 in all correspondence.