Role Purpose
To safely and accurately execute bottle packing operations for potent OSD products in compliance with cGMP, containment, quality, and EHS requirements, ensuring correct packing, documentation, and operator safety.
Key Roles & Responsibilities
A. Bottle Packing Operations
- Operate bottle packing lines for potent products as per approved BPR and SOPs.
- Perform activities including bottle feeding, tablet filling, cotton induction, capping, sealing, labeling, and packing.
- Ensure correct use and functioning of counting/sensor systems (electronic/mechanical counters).
- Conduct in-process checks such as fill count, seal integrity, label correctness, and pack appearance at defined intervals.
- Ensure pack reconciliation, accountability of printed materials, and handling of rejects and rework as per procedure.
B. Potent Area & Containment Compliance
- Strictly follow high-potency handling and containment procedures during packing operations.
- Use prescribed PPE and RPE (air suit / respirator / PAPR) at all times in the potent packing area.
- Prevent operator exposure, cross-contamination, and product mix-ups.
- Adhere to controlled material movement, area segregation, and one-product-one-area principles.
C. Line Clearance & Changeover
- Perform line clearance before batch start and after batch completion as per SOP.
- Verify correct batch details, components, and documentation before starting operations.
- Support product and batch changeover, ensuring removal of previous batch materials and labels.
- Ensure equipment status labeling is correctly displayed.
D. Documentation & cGMP Compliance
- Complete all entries in BPR, packaging logbooks, reconciliation sheets, and IPC records in real time.
- Follow Data Integrity (ALCOA+) principles without overwriting or back-dating.
- Immediately report and document deviations, discrepancies, or abnormalities.
- Support internal, customer, and regulatory audits.
E. Safety, EHS & Quality
- Follow all EHS and safety procedures applicable to potent packing operations.
- Immediately report spills, exposure risks, line abnormalities, or unsafe conditions.
- Ensure proper segregation and disposal of potent waste, rejected tablets, labels, bottles, and printed materials.
- Maintain housekeeping and 5S standards in the packing area.
F. Teamwork & Continuous Improvement
- Coordinate with IPQA, QC, Warehouse, and Engineering teams during operations and issues.
- Participate in Kaizen, OPLs, and training programs.
- Support training of new operators under supervision.
Qualifications Required
Educational Qualification
- iploma in
- Mechanical / Electrical (with pharma experience)
- 6-12 with relevant pharma packing experience may also be considered.
Experience
- 6-12 years of experience in OSD bottle packing, preferably in potent / high-potency products.
- Exposure to controlled / potent packing areas is preferred.
