Officer - Formulation Packaging (Pune Biotech, MH, IN)
Lupin
- Experience
- 2+ yrs
- Location
- Pune, Maharashtra, India
- Job type
- Full-time
Required skills
- SOPs
- BMR/BPR
- documentation systems
About the role
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.
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.
About Lupin
Develops and manufactures generic and branded pharmaceutical products globally.
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