Senior Officer – QA Validation | Bharat Serums | Ambernath
Job Overview
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Date PostedJuly 15, 2023
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Location (State / UT)
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Expiration dateFebruary 26, 2026
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Experience2 Years, 4 Years
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GenderAny
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Desired QualificationBachelor Degree, Master’s Degree
Job Description
Responsibilities:
- Responsible for planning and review of Validation and Qualification activities in the Parenteral Facility.
- Responsible for planning, organizing, and executing of periodic re-qualification activity of equipment and system. (Sterilizers, Compact Line, Lyophilizer)
- To prepare and execute protocol and reports of periodic re-qualification of process equipment and miscellaneous study.
- To prepare and review the URS, design qualification, installation qualification, and operational qualification protocol.
- To prepare and execute performance qualification protocol and report. To prepare and review protocol and reports of temperature mapping periodic re-qualification.
- To plan and coordinate with cross-functional departments for smooth execution of qualification and validation activities.
- Responsible for review of the technical specification of newly procured equipment and instrument w.r.t QA Validation / Qualification perspective.
- Responsible for review of FAT protocol and execution of FAT of new equipment and system.
- Execution of computer system validation (SCADA/PLC/Lab Software)
Additional Knowledge is required with regard to:
- MS Office, Adobe Acrobat Pro, Microsoft Visio, KAYE, MS Project
- GMP, cGMP, GDP, All guidelines w.r.t validation and qualifications for Parenteral Manufacturing Facility.
Qualification: B.Pharma, M.Pharma
Experience: 2-4 Years
