Production Sterile - Packing Operator

PeopleStrong; Daman; On-site; INR 180,000 - 220,000; Full time

Job summary

PeopleStrong seeks an experienced operator for aseptic processing and sterile packing of injectables. The role covers machine operation, aseptic inspection, line clearance, seal testing, material handling, and meticulous record-keeping under ALCOA+ guidelines in a controlled cleanroom.

Responsibilities include troubleshooting, yield reconciliation, and ensuring regulatory-ready documentation for audits and inspections within a sterile packing suite.

Qualifications

• Diploma or ITI in a relevant field.
• Aseptic packing and sterile packaging experience preferred.
• Awareness of ALCOA+ data integrity in batch records.

Responsibilities

• Sterile Packing Machine Operation: Set up, assemble, and operate packaging machinery for injectables.
• Aseptic & Visual Inspection: Perform online visual inspection for clarity, particulates, container integrity, volume, and sealing defects.
• Line Clearance Execution: Execute line clearance during product changeovers to prevent cross-contamination.
• Leak & Seal Testing: Conduct in-process seal testing and track checks for crimping/sealing.
• Packaging Material Handling: Load primary/secondary materials under controlled packaging environment standards.
• Logbook & BPR Entries: Record real-time data and downtime in Batch Packing Records per ALCOA+ rules.
• Troubleshooting & Maintenance: Identify minor faults and assist maintenance during changeovers.
• Material Yield & Reconciliation: Reconcile packaging components at end of shift for material balance.
• Audit & Cleanroom Compliance: Keep packing suite clean and ready for inspections (USFDA, EU Annex 1, WHO).
• EHS & Cleanroom Hygiene: Follow PPE and 5S discipline.

Education

Diploma/ITI

Diploma ITI D. Pharm

Job description

Aseptic Processing Packing Blister Packaging

Diploma/ITI

Diploma ITI D. Pharm

CERTIFICATION

Working Language

Job Description

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.