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Compliance and Quality Manager
1 week ago
Job Summary:
The Compliance and Quality Manager will oversee site compliance with cGMP regulations and internal quality procedures. This includes managing investigations, product quality complaints, CAPAs, deviations, and change controls. The successful candidate will ensure adherence to SOPs and policies, provide assistance during regulatory, corporate, and internal audits, and maintain the Global Documents implementation tracker.
Main Responsibilities:
- Oversight of site compliance with cGMP regulations and internal quality procedures
- Management of investigations, product quality complaints, CAPAs, deviations, and change controls
- Adherence to SOPs and policies
- Assistance during regulatory, corporate, and internal audits
- Maintenance of the Global Documents implementation tracker
- Development and implementation of global procedures at the site
- Change control management in Trackwise
- Qualification protocols and reports for equipment and product validations/verifications