19 Sep
|
TechInvention Lifecare
|
Maharashtra
19 Sep
TechInvention Lifecare
Maharashtra
Job Title: Officer / Executive – Sterile Formulation & FillingDepartment: Production / Operations (Injectable Line)Experience Required: 3 to 7 Years in Sterile Injectables or Biologics/Vaccine ManufacturingEducation: 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 CompetenciesDeep operational expertise in supervising formulation and filling operations.Well-versed in troubleshooting filling machine, isolatorHave strong hands on isolator technology and aseptic practices.
📌 Supervisor (Officer / Executive) – Vaccine Production (Maharashtra)
🏢 TechInvention Lifecare
📍 Maharashtra