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Sr Associate Packing & Visual Inspection

Par Health -
Indore, Madhya Pradesh

Apply Now

Job details

Full-time
12 days ago

Qualifications

B.Sc
Master's degree
Science
Bachelor's degree
Production planning
B.E.
Lean manufacturing

Full job description

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.

Apply Now

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Key Responsibilities

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Visual Inspection

Packing Operations

Equipment Management

Documentation & Compliance

Quality & Regulatory Compliance

Team Management

Continuous Improvement

Safety & EHS

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