Role & Responsibilities
Packing Operation Execution:
- Check and monitor cleanliness, maintenance, and equipment upkeep.
- Ensure proper storage of materials and products.
- Monitor and maintain status labeling of containers, equipment, and materials.
- Follow cGMP and perform online documentation.
- Handle packing activities including line clearance, machine setting, material reconciliation, and rejection analysis.
- Carry out in-process checks and BPR entries.
- Use systems: SAP, Trackwise, CipDox, Goose, Documentum, CENTRACK, PRAMAAN, LMS, E-Track, LEUCINE.
- Handle new product registration and site transfer activities.
- Handle SOPs, training, and documentation.
- Calibrate equipment and maintain records.
- Coordinate PPM and equipment qualification.
- Train staff and workmen.
- Coordinate with other departments.
- Maintain discipline.
- Protect product and materials from spillage or deterioration.
- Review and sign packing documents.
- Supervise and allocate duties to staff.
- Track in-house calibration.
- Discuss daily work with Department Head.
Validation:
- Participate in packing, process, and cleaning validations.
- Participate in study protocol and machine trials.
Quality Management System:
- Document changes with QA.
- Report and investigate deviations.
- Handle Trackwise deviation closure.
- Investigate incidents and complaints.
- Prepare and review FMECA.
Environment, Health & Safety:
- Follow safety and environmental guidelines.
- Operate machines safely with minimal rejection and maximum output.
Preferred Candidate Profile
- B.Pharm / M.Pharm
- 10+ years pharma packing experience
