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), energetic 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.