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0.0 - 2.0 years
2 - 3 Lacs
ahmedabad
Work from Office
Key Responsibilities: Audit Readiness (IT Focus) Ensure IT systems, documentation, and infrastructure are always audit-ready for external and internal audits. Lead or support IT-related audit sessions, walk-throughs, and responses during sponsor audits , regulatory inspections , and internal QA reviews . Maintain an organized repository of IT evidence including SOPs, validation documentation, access logs , and change control records . IT Compliance & Documentation Author, review, and maintain IT SOPs , Policies etc. in accordance with regulatory requirements. Ensure that IT documentation complies with 21 CFR Part 11 , EU Annex 11 , and GAMP 5 guidelines. Conduct periodic reviews of IT system...
Posted 2 months ago
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