Job Description Summary
To lead and manage Visual Inspection and Packing operations for sterile injectable products while ensuring compliance with cGMP, regulatory requirements, safety standards, and production schedules. The role is responsible for achieving quality, productivity, and operational excellence in manual/automatic visual inspection and secondary packaging activities.
Job Description
roduction Operations
- Plan and execute daily Visual Inspection and Packing activities as per production schedule.
- Ensure timely completion of batches with optimum manpower utilization.
- Monitor productivity, yield, and line efficiency.
- Ensure adherence to batch manufacturing and packaging records.
- Coordinate with Manufacturing, Warehouse, QA, QC, Engineering, and Planning for smooth operations.
Visual Inspection
- Manage manual and automated visual inspection operations.
- Ensure inspectors are qualified and periodically requalified.
- Monitor defect trends and improve defect detection capability.
- Ensure AQL inspections are performed as per procedures.
- Investigate high rejection trends and implement corrective actions.
- Ensure compliance with Annex 1, USP, and internal inspection procedures.
Packing Operations
- Lead secondary packaging activities including:
- Cartoning
- Labeling
- Serialization (if applicable)
- Bundling
- Shipper packing
- Ensure correct line clearance before batch initiation.
- Prevent mix-ups and cross-contamination.
- Verify reconciliation of printed packaging materials.
Compliance & Documentation
- Ensure strict compliance with cGMP, GDP, SOPs, and Data Integrity requirements.
- Review batch records and packing documents.
- Participate in deviation, CAPA, Change Control, OOS, and Risk Assessments.
- Ensure audit readiness at all times.
People Management
- Lead and supervise operators, technicians, and line leaders.
- Conduct shift meetings and daily production reviews.
- Identify training needs and develop team competency.
- Manage manpower planning and shift allocation.
- Drive employee engagement and performance improvement.
Continuous Improvement
- Implement Lean Manufacturing and Six Sigma initiatives.
- Improve OEE, line efficiency, and labor productivity.
- Reduce rejection, downtime, and material wastage.
- Support automation and digitalization initiatives.
Equipment Management
- Ensure proper operation of:
- Manual/Automatic Visual Inspection Machines
- Cartoning Machines
- Labeling Machines
- Check Weighers
- Serialization Systems
- Shrink Wrappers
- Case Packers
- Coordinate preventive maintenance with Engineering.
- Support equipment qualification (IQ/OQ/PQ).
Regulatory & Audit Support
- Support regulatory inspections (USFDA, MHRA, EMA, WHO, ANVISA, etc.).
- Present department documents during audits.
- Ensure timely closure of audit observations.
Safety & EHS
- Ensure compliance with EHS policies.
- Promote safe work practices.
- Participate in incident investigations and corrective actions.
