- Preparation and Review of Standard Operation Procedures.
- Review of executed BMR, BPR, ECR, etc.,
- Responsible for Change control management.
- Preparation and Review of Annual product review.
- Responsible QA Release.
- Responsible for Process Performance Qualification and Cleaning Validation.
- Handling of Deviation.
- Responsible for OOS, OOT investigation related to manufacturing.
- Responsible for reviewing of Line Clearance activities.
- Responsible for Finished product sampling