Long Description
Execute and supervise 100% visual inspection of prefilled syringes (PFS) and vials in accordance with approved SOPs and defined inspection standards.
Maintain accurate, real-time documentation in BMR/BPR, equipment logbooks, inspection records, and rejection records.
Execute and supervise training of inspectors and operators on defect identification, defect classification, and inspection techniques.
Evaluate inspector performance, manage inspector fatigue, and ensure strict adherence to approved SOPs.
Ensure discipline, proper gowning compliance, and acceptable cleanroom behavior in the inspection area.
Ensure compliance with data integrity (ALCOA+) principles throughout inspection and documentation activities.
Review inspection data and ensure accurate reconciliation of inspected, accepted, rejected, and destroyed quantities.

Competencies

Education

Graduation in Pharmacy

Post Graduation in Biotechnology

Work Experience

Minimum 2 to 4 years of relevant experience in visual inspection of sterile injectable Vial and PFS products, along with proven experience in handling and facing regulatory audits.

📌 Officer Fill Finish Facility Pune (India)
🏢 Important Company of the Sector
📍 India