Job Description Summary

To supervise and coordinate Visual Inspection (manual and automated) and secondary packing operations for sterile injectable products, ensuring production targets are achieved while maintaining compliance with cGMP, data integrity, product quality, and global regulatory requirements (USFDA, EU GMP, MHRA, WHO, PIC/S).

Job Description

Key Responsibilities

Production Operations

• Supervise daily Visual Inspection and Packing activities as per the production schedule.
• Ensure timely completion of batches with optimum utilization of manpower, equipment, and materials.
• Monitor line productivity, batch yields, and packing efficiency.
• Coordinate with Production Planning, QA, QC, Warehouse, Engineering, and Maintenance for smooth execution of operations.
• Ensure proper line clearance before batch commencement and product changeover.

Visual Inspection

• Supervise manual and automated visual inspection of sterile injectable products (vials, ampoules, prefilled syringes, cartridges).
• Ensure inspectors are trained, qualified, and periodically requalified.
• Verify adherence to approved defect kits and inspection standards.
• Monitor rejection trends and investigate abnormal rejection rates.
• Ensure AQL sampling and finished product inspections are performed as per approved procedures.
• Support investigations related to cosmetic and particulate defects.

Packing Operations

• Supervise secondary packaging activities, including:
  • Labeling
  • Cartoning
  • Leaflet insertion
  • Serialization and aggregation (where applicable)
  • Bundling and shipper packing
• Ensure reconciliation of printed packaging materials.
• Prevent product mix-ups and labeling errors.
• Monitor packing line efficiency and minimize downtime.

Equipment Management

• Supervise operation of:
  • Automatic Visual Inspection Machines
  • Manual Visual Inspection Stations
  • Labeling Machines
  • Cartoning Machines
  • Check Weighers
  • Serialization Systems
  • Shrink Wrappers
  • Case Packers
• Coordinate preventive maintenance and equipment breakdown activities.
• Support equipment qualification (IQ/OQ/PQ), FAT/SAT, and validation activities.

Documentation & Compliance

• Review Batch Packaging Records (BPR), inspection records, and equipment logbooks.
• Ensure compliance with cGMP, GDP, ALCOA+, and Data Integrity requirements.
• Verify accurate documentation of production and in-process activities.
• Ensure timely completion and review of all production records.

Quality & Regulatory Compliance

• Ensure compliance with SOPs, packaging specifications, and visual inspection procedures.
• Participate in deviation investigations, CAPA, Change Control, Risk Assessments (FMEA), and root cause analysis.
• Support regulatory inspections (USFDA, EU GMP, MHRA, WHO, PIC/S, etc.) and customer audits.
• Ensure audit readiness and timely closure of audit observations.

Team Management

• Supervise operators, inspectors, and technicians across shifts.
• Plan manpower allocation based on production requirements.
• Conduct shift handovers and daily production meetings.
• Identify training needs and ensure periodic qualification of personnel.
• Monitor team performance and promote a culture of quality and continuous improvement.

Continuous Improvement

• Drive initiatives to improve:
  • Overall Equipment Effectiveness (OEE)
  • Packing line efficiency
  • Right First Time (RFT)
  • Batch cycle time
  • Productivity
  • Reduction in inspection and packing rejections
• Support Lean Manufacturing, Six Sigma, and digital manufacturing initiatives.

Safety & EHS

• Ensure compliance with EHS policies and safe work practices.
• Participate in incident investigations and implementation of corrective actions.
• Maintain good housekeeping and 5S standards within the department.

Qualifications

• B.Pharm / M.Pharm
• B.Sc. / M.Sc. (Life Sciences)
• B.E./B.Tech (relevant discipline) may also be considered.