Title: Temp CMO Associate
Date:
Aug 6, 2022
Location:
Company:
- Qualify and support assigned CMO aligned with the Sun Pharma Quality Management Systems and provide reports as required.
- Implement, report and monitor CMO Quality Metrics and ensure identification and implementation of improvements needed through routine CMO business review.
- Implement and maintain Regional CMO data in the Global CMO database.
- Ensure the Quality Assurance Agreements which are created and maintained according to Sun Pharma requirements, are regularly reviewed and followed.
- Conduct review and approve batch release documentation.
- Support significant quality issues associated with Drug Products or Medical Devices originating from assigned CMO (complaints, deviations, recalls, counterfeits and product tampering, stability failures, etc.) appropriately and in a timely fashion.
- Maintain annual auditing program, participate in technical visits and/or audits, manage action plans and follow up on agreed upon CAPAs.
- Manage and oversee complaint, change control, variation filing modules for CMO activity.
Manage and oversee complaint module for Site.