Purpose Responsible for the maintenance and continuous improvement of the Change Control systems and processes. Ensure GMP compliance with the change control process.
Key Responsibilities - Ensure adherence to the Change Control management systems and processes
- Develop competency and proficiency in the QA Change Control process and the associated tools, supporting the delivery of training for change users as needed
- Evaluate Change Control requests for process, validation, regulatory and product impact
- Coordinate the review and approval process of change requests to ensure timely execution of changes
- Ensure all site major changes are managed appropriately to meet the expectation of the global change control board and meet site project timelines
- Participate in cross‑functional and cross‑site change management forums
- Collaborate with departments to ensure change control activities are executed efficiently and...