Supervisor (Officer / Executive) Vaccine Production
Techinvention Lifecare Pvt. Ltd. · Mumbai · onsite · Posted 32d ago
Not disclosed3–7 yrsfulltimeSourced from
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About this role
- 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.
Sourced from foundit
Skills
Dynamic smoke profiling studiesEquipment qualification validationHEPA filter leak assessmentsIPC SCADA systemsIsolator technologyPAO challenge testingAseptic practicesQMS elementsMedia Fills