20 Sep
|
TechInvention Lifecare
|
Mumbai
20 Sep
TechInvention Lifecare
Mumbai
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- Job Title: Officer / Executive – Sterile Formulation & Filling
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- Department: Production / Operations (Injectable Line)
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- Experience Required: 3 to 7 Years in Sterile Injectables or Biologics/Vaccine Manufacturing
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- Education: B.Pharm / M.Pharm / B.Tech (Biotechnology) / M.Sc. (Microbiology/Biotech)
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- nKey Responsibilities includes:
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- 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.
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- Regulatory Compliance & Data Integrity: Ensure complete shift compliance with US FDA 21 CFR Part 11..
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- 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).
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- Documentation: Prepare and Review of SOP , Protocol , report and other QMS elements.
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nTechnical Competencies
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- Deep operational expertise in supervising formulation and filling operations.
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- Well-versed in troubleshooting filling machine , isolator
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- Have strong hands on isolator technology and aseptic practices.
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📌 Supervisor (Officer / Executive) - Vaccine Production (Mumbai)
🏢 TechInvention Lifecare
📍 Mumbai