Job Description & How to Apply Below
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.
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