Job Description Summary

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.