Officer Fill Finish Facility

Long Description

1. Execute and supervise 100% visual inspection of prefilled syringes (PFS) and vials in accordance with approved SOPs and defined inspection standards.


2. Maintain accurate, real-time documentation in BMR/BPR, equipment logbooks, inspection records, and rejection records.


3. Execute and supervise training of inspectors and operators on defect identification, defect classification, and inspection techniques.


4. Evaluate inspector performance, manage inspector fatigue, and ensure strict adherence to approved SOPs.


5. Ensure discipline, proper gowning compliance, and acceptable cleanroom behavior in the inspection area.


6. Ensure compliance with data integrity (ALCOA+) principles throughout inspection and documentation activities.


7. Review inspection data and ensure accurate reconciliation of inspected, accepted, rejected, and destroyed quantities.

Competencies

Education

Work Experience