Qualification: M.Sc./M.Pharm./M.Tech./B.Pharm. or relevant life sciences qualification
Key Responsibilities:
- Perform IPQA activities for biosimilar manufacturing operations.
- Ensure compliance with GMP, SOPs and regulatory requirements during manufacturing.
- Perform line clearance, area clearance and in-process checks.
- Review batch manufacturing records, logbooks and other GMP documentation.
- Handle deviations, CAPA, change controls and incident investigations.
- Coordinate with Manufacturing, QC and other cross-functional teams for quality-related activities.
- Support internal, customer and regulatory audits.
Preferred: Experience in Biosimilars/Biologics/Protein manufacturing with exposure to IPQA and GMP compliance.