Role Summary
The Executive Packing is responsible for daytoday packing operations of Oral Solid Dosage (OSD) formulations, ensuring compliance with
cGMP, USFDA, safety, and quality standards. The role focuses on effective manpower handling, adherence to SOPs, achieving production targets, documentation, and audit readiness.
Key ResponsibilitiesPacking Operations
- Execute and supervise primary and secondary packing operations for OSD products (blister, strip, bottle, carton, shipper).
- Operate and oversee packing equipment such as blister packing machines, cartoners, labellers, bottle lines, etc.
- Ensure packing activities are carried out as per approved BMR/BPR, SOPs, and shift plans.
- Achieve daily/shift production targets while maintaining quality and compliance.
GMP & Compliance
- Ensure adherence to cGMP, USFDA, and company quality standards during packing operations.
- Maintain proper line clearance before and after batch completion.
- Follow data integrity (ALCOA+) principles in documentation and records.
- Ensure personnel follow gowning, hygiene, and safety requirements.
Documentation & Records
- Complete and review Batch Packing Records (BPRs) accurately.
- Maintain equipment logbooks, usage records, and cleaning records.
- Initiate and support deviations, incidents, and CAPAs related to packing operations.
Manpower & Shift Handling
- Allocate manpower efficiently across packing lines.
- Train packing operators on SOPs, safety practices, and GMP requirements.
- Monitor individual and line performance to improve productivity and reduce losses.
Coordination & Support Functions
- Coordinate with Quality Assurance, Quality Control, Engineering, and Warehouse teams for smooth operations.
- Support changeovers, new product introductions, and scaleup activities.
- Ensure timely availability of packing materials and report shortages proactively.
Audit & Inspection Support
- Support USFDA, MHRA, WHO, customer, and internal audits.
- Handle audit queries related to packing operations and documentation.
- Ensure line and document readiness for inspections at all times.
Qualifications & ExperienceEducation
- Bachelor's degree in Pharmacy / Science / Engineering (B.Pharm / B.Sc. / B.E. or equivalent)
Experience
- 26 years of experience in OSD packing operations within a USFDAapproved pharmaceutical manufacturing plant
Technical Knowledge & Skills
- Strong knowledge of OSD packing processes and equipment
- Understanding of cGMP, USFDA regulations, and data integrity
- Handson experience with BPR execution and line clearance
- Basic knowledge of OEE, yield, and productivity improvement
Behavioural Competencies
- Good communication and coordination skills
- Ability to work in shifts
- Problemsolving and decisionmaking ability
- Compliancedriven and detailoriented approach
Preferred
- Prior exposure to USFDA inspections
- Experience in multiple packing formats (blister/bottle/strip)
