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Job Description
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.