We are seeking a GMP Coordinator for our location in Göttingen to support the GMP & Compliance Manager in ensuring GMP compliance and managing quality agreements.
Requirements
- Supporting the GMP & Compliance Manager (Team Leader) in ensuring GMP compliance
- Managing quality agreements
- Supporting the team in dealing with electronic quality management systems (eQMS)
- Creating and processing internal changes/ deviations in eQMS
- Supporting the team in handling internal deviations systemically and content-wise
- Monitoring and coordinating internal deviations
- Monitoring the timely implementation of corrective/preventive measures and effectiveness tests
- Trending and tracking (regular reporting)
- Participating in global projects as a 'Change Agent' to implement eQMS (new or updated) within CSL
- Supporting the application / withdrawal of user access in various eQMS
- Regular user review of electronic systems used in the department
- Supporting the creation and update of SOPs in compliance with global guidelines / SOPs
- Literature research in the area of EU-GMP guidelines / EU regulations / local regulations and laws
Benefits
- Christmas and holiday pay
- Voluntary bonus payment
- Opportunities for remote work
- Bike leasing with discounted conditions