Sr Executive CSV

1 week ago


Bengaluru, Karnataka, India Opportune Solutions Full time ₹ 9,00,000 - ₹ 12,00,000 per year

Planning and performing of Computer Systems Validation in regulated environment. Respond CSV schedule to ensure all quality, manufacturing and engineering systems remain qualified to current GxP and GAMP5 requirements. IT systems interface

Required Candidate profile

Working knowledge on US FDA 21 CFR Part 11, EU Annex 11 and GAMP 5. Develop CFR Part 11 csv plans, qualifications test protocols, traceability matrices, reports, IQ/OQ protocols; IT system interface


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