Supervisor (Officer / Executive) Vaccine Production

• Job Title: Officer / Executive – Sterile Formulation & Filling
• Department: Production / Operations (Injectable Line)
• Experience Required: 3 to 7 Years in Sterile Injectables or Biologics/Vaccine Manufacturing
• Education: B.Pharm / M.Pharm / B.Tech (Biotechnology) / M.Sc. (Microbiology/Biotech)

Key Responsibilities includes:

• Line Supervision: Supervise real-time filling operations inside the Grade A Isolator core. Monitor parameters across check-weighers, line speeds, and robotic nest pickup functions via the integrated IPC SCADA systems.

• Regulatory Compliance & Data Integrity: Ensure complete shift compliance with US FDA 21 CFR Part 11..

• Validation & Aseptic Processing Support: Participate directly in and supervise the execution of equipment qualification / validation and Aseptic Process Simulations (APS / Media Fills), dynamic smoke profiling studies, and HEPA filter leak assessments (PAO challenge testing).

• Documentation: Prepare and Review of SOP , Protocol , report and other QMS elements.

Technical Competencies

• Deep operational expertise in supervising formulation and filling operations.
• Well-versed in troubleshooting filling machine , isolator
• Have strong hands on isolator technology and aseptic practices.