Assistant/Dy. Manager - CSV (Computer system validation)

8 - 13 years

10 - 13 Lacs

Posted:2 weeks ago| Platform: Naukri logo

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Job Type

Full Time

Job Description

To respond CSV schedule to ensure all quality, manufacturing and engineering systems remain qualified to current GxP and GAMP5 requirements. Injectables exposure is must. Planning and performing(CSV). CSV-related deviations, change control documents.

Required Candidate profile

Exp of US FDA 21 CFR Part 11, EU Annex 11 & GAMP 5, Software testing requirements for SCADA, MES, is MUST. Develop CFR Part 11 CSV plans, traceability matrices, reports, IQ/OQ protocols.

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Opportune Solutions

Consulting

Houston

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