QA Manager (m/f/d)
- Support and drive implementation of Annex 1 requirements during implementation in the Clinical Supply Centre for sterile Drug Product (Parenterals) within IMP Switzerland
- Responsible to represent Quality Assurance while driving all activities related to a successful implementation of Annex 1 within IMP Quality Operations Switzerland
- Maintaining and continuously supporting all Qualification/Validation and parenteral manufacturing activities within IMP Quality Operation Switzerland
- Support and collaborate with Quality Assurance Managers within IMP Quality Operations Switzerland
- Provide sound technical and quality assurance expertise for review and approval of quality related documents (e.g. SOPs, qualification, validation documents)
- Partner with all stakeholders within the Clinical Supply Centre as well as with Technical Development and provide guidance to ensure successful delivery of the Annex 1 implementation goals
- Support your area of responsibility at HA inspections and internal audits
- University Degree in Engineering, Pharmacy, Biology, Biochemistry, Chemistry, Life Science, Pharmacy or equivalent
- Proven experience in a GMP regulated environment and with Quality Systems, Quality assurance and OT
- Experience in Quality Risk Management as well as in performing risk assessments (e.g. FMEA)
- Experience in Qualification / Validation as well as all all activities around parenteral manufacturing
- Fluent in German, English B2
- Fast learner, strong team-player with a high level of self-motivation and with ability to prioritize, simplify and connect the dots
- Proven ability to work independently and in a team towards results
- Excellent planning and organizing skills in order to manage multiple tasks at the same time as well as analytical capabilities and an innovative manner of solving problems
- Unlimited contract possible
- A very renowned company
À propos de l'entreprise