About the role
Packing Sterile: Operator Sterile Packing Machine Operation: Set up, assemble, and operate primary and secondary packaging machinery for injectables (vials, ampoules, pre-filled syringes, BFS/FFS) in compliance with BPR specifications. Aseptic & Visual Inspection: Perform online visual inspection (or monitor automated inspection systems) for clarity, particulate matter, container integrity, volume levels, and sealing defects. Line Clearance Execution: Execute thorough area cleaning, equipment sanitation, and line clearance protocols (Type A/B) during product changeovers to prevent cross-contamination or line mix-ups. Leak & Seal Testing: Conduct routine in-process seal integrity testing (dye ingress, high-voltage leak detection, vacuum decay) and track parameter checks for aluminum cap crimping or ampoule sealing. Packaging Material Handling: Receive, verify batch details, and load primary/secondary materials (aluminum caps, trays, cartons, leaflets, outer shippers) under controlled packaging environment standards. Logbook & BPR Entries: Record real-time machine operating data, downtime, rejected quantities, and room conditions in Batch Packing Records (BPR) and equipment logbooks adhering to ALCOA+ rules. Troubleshooting & Maintenance: Identify minor mechanical or pneumatic machine faults during operations (e.g., optical sensor misalignment, star-wheel jams) and assist maintenance technicians with changeovers. Material Yield & Reconciliation: Calculate and reconcile used, unused, and rejected packaging components at the end of each shift to ensure accurate batch material balances. Audit & Cleanroom Compliance: Keep the sterile packing suite, machine surfaces, and documentation organized, clean, and ready for internal and external regulatory inspections (USFDA, EU Annex 1, WHO). EHS & Cleanroom Hygiene: Adhere to cleanroom zoning guidelines, wear mandatory personal protective equipment (PPE), follow strict personal hygiene standards, and maintain workplace 5S discipline.