Global Quality Assurance Manager
2 maanden geleden
We are seeking a highly skilled and experienced professional to join our team as a Group RP Manager at Abacus Medicine Group. As a key member of our QA organization, you will be responsible for leading a dynamic global team and ensuring quality excellence in EU medicinal product supply.
Main Responsibilities- Manage the global RP team and ensure clear communication and oversight
- Strive for quality excellence and continuous improvement in EU medicinal product supply
- Coordinate and support recall operations for medicinal products
- Effectively manage quality or distribution complaints
- Ensure the approval of suppliers and customers
- Approve subcontracted activities that may impact GDP
- Regularly monitor GDP suppliers
- Ensure self-inspections are performed at appropriate intervals
- Experience working within QA or a similar role in the pharmaceutical industry
- At least 5 years' experience as a people manager
- Experience in setting up new wholesale licenses is preferable
- Experience as an RP
- Excellent working knowledge and application of the current EU Guide to GDP
- Good working knowledge of Quality Risk Management
- Proven experience in hosting and supporting regulatory inspections
The QA organization is mainly located in Hungary, Netherlands, and Denmark, with a total of around 100 employees. The majority of the QA team is situated in Hungary.
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