Key Responsibilities:
- Perform aseptic filling operations for injectable products (vials/ampoules/syringes).
- Ensure proper line setup, machine operation, and changeover activities.
- Monitor critical process parameters during filling operations.
- Maintain strict compliance with aseptic practices and GMP guidelines.
- Perform line clearance before and after batch operations.
- Handle and document in-process checks and production records (BMR).
- Coordinate with QA/IPQA for in-process approvals.
- Identify and report deviations, incidents, and implement CAPA.
- Ensure cleaning, sterilization, and maintenance of equipment.
- Follow safety and hygiene standards in sterile areas.
