- Plan and execute primary and secondary packing activities for sterile injectable products as per the approved production schedule.
- Ensure all packing operations are performed in compliance with cGMP, SOPs, regulatory requirements, and site quality standards.
- Monitor and achieve daily packing targets while maintaining product quality, safety, and operational efficiency.
- Ensure line clearance, area readiness, material verification, and equipment availability before starting packing operations.
- Coordinate the issuance, consumption, reconciliation, and return of packing materials.
- Verify printed packing materials, product details, batch information, and coding before and during packing activities.
- Maintain and review Batch Packing Records, equipment logs, area logs, checklists, and other GMP documentation.
- Perform SAP transactions related to material issuance, consumption, reconciliation, batch confirmation, and inventory movement.
- Handle QMS activities, including deviations, change controls, CAPA, incident investigations, risk assessments, and related documentation.
- Support investigation of packing-related discrepancies, market complaints, and non-conformances, and ensure timely implementation of corrective and preventive actions.
- Coordinate with Production, Quality Assurance, Quality Control, Warehouse, Engineering, Planning, and other functions for uninterrupted packing operations.
- Ensure timely dispensing and availability of packing materials in coordination with Warehouse and Planning teams.
- Monitor packing line performance; identify operational gaps, and support productivity and process improvement initiatives.
- Ensure proper cleaning, operation, and upkeep of packing equipment and work areas.
- Coordinate with Engineering for preventive maintenance, breakdown resolution, and equipment qualification activities.
- Ensure compliance with data integrity requirements and good documentation practices.
- Support internal audits, regulatory inspections, and customer audits by ensuring area and documentation readiness.
- Train operators and contractual workforce on SOPs, cGMP, safety requirements, and packing procedures.
- Ensure compliance with Environment, Health and Safety requirements and promote safe working practices on the shop floor.
- Maintain proper shift handover and communicate pending activities, breakdowns, quality concerns, and production status to the next shift.
- Perform any additional responsibilities assigned by the reporting manager based on operational requirements.
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