
Key Responsibilities:
- Lead all production operations and manufacturing teams.
- Lead aseptic manufacturing operations including CIP, SIP, Autoclaving, Isolator, and VHP systems.
- Oversee aseptic filtration, filling, and packaging activities for PFS, Vials, and Cartridges.
- Oversee Media Fill activities and ensure compliance with aseptic processing requirements.
- Ensure compliance with cGMP, SFDA, and international regulatory requirements.
- Manage QMS activities including Change Control, Deviations, CAPA, Investigations, and SOPs.
- Ensure proper batch manufacturing and packaging documentation.
- Coordinate with QA, QC, Engineering, Warehouse, and Supply Chain.
- Manage manpower planning and daily production activities.
- Drive continuous improvement initiatives and mentor the production team.
Requirements:
- B.Pharm, M.Pharm, M.Sc., or Bachelor's/Master's degree in Pharmacy, Biotechnology, Chemical Engineering, or a related field.
- 20+ years of experience in sterile injectable and/or biosimilar pharmaceutical manufacturing.
- Strong expertise in aseptic manufacturing, filtration, filling, and packaging operations.
- Hands-on experience with PFS, Vials, Cartridges, CIP, SIP, Autoclaves, Isolators, and VHP systems.
- Strong knowledge of GMP, SFDA, and international regulatory requirements.
- Excellent leadership, communication, and people management skills.
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