- Ensure compliance with cGMP (Current Valuable Manufacturing Practices) and GDP (Good Documentation Practices) across General, Control, and Aseptic areas
- Supervise overall injectable production activities during the assigned shift
- Ensure all equipment and manufacturing lines are validated and calibrated before use
- Perform and verify line clearance activities prior to batch commencement
- Handle Change Control, Deviations, Investigations, and CAPA (Corrective and Preventive Action) processes
- Review, approve, revise, and implement SOPs (Standard Operating Procedures) for sterile manufacturing
- Monitor execution of production plan vs actual output on daily and monthly basis
- Ensure strict adherence to aseptic techniques and contamination control practices
- Oversee cleaning, sanitization, and environmental monitoring activities
- Coordinate with QA, QC, Engineering, and Warehouse for seamless operations
- Review and maintain online production and batch documentation
- Responsible for preparation & review of the all-master documents of production
- Responsible to update on self-hygiene
- Responsible to attend the training as per training schedule and to ensure training of the team as per TNI
- Support audit readiness and regulatory inspections as required
Additional Responsibilities:
- Activities other than defined in the job responsibility are to be done, as per the requirement of HOD, by following HODs instruction and guidance.
- Responsible to give training to all the subordinates, technicians, and operators of the department. Responsible to update on self-hygiene.
- Responsible to attend the training as per training schedule and to ensure training as per TNI.