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Job Title: SR. OFFICER – QA – VALIDATION
Experience: From 2 to 4 year(s) of experience
Location: Mumbai Suburban,Maharashtra
Salary: Not Disclosed by Recruiter
Industry: Pharmaceutical & Life Sciences
Department: Quality Assurance
Role Category: Production & Manufacturing
Employment Type: Full Time, Permanent
Key Skills
KAYEdata validationcgmpdesign qualificationgmp
FAT protocolComputer System validation
Skills highlighted with ‘‘ are preferred keyskills
Education
UG:B.Pharma in Pharmacy
PG:M.Pharma in Any Specialization
Job Description
- Responsible for plan and review of Validation and Qualification activities in 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 co-ordinate with cross-functional department for smooth execution of qualification and validation activities.
- Responsible for review of technical specification of newly procured equipment and instrument w.r.t QA Validation / Qualification prospective.
- Responsible review of FAT protocol and execution of FAT of new equipment and system.
- Execution of computer system validation (SCADA/PLC/Lab Software)
Additional Knowledge required with regards 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.
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