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1.0 - 4.0 years
3 - 4 Lacs
sangareddy, patancheru, hyderabad
Work from Office
Role & responsibilities Prepare and harmonize CQA SOPs, forms, and schedules. Manage document control: issuance, archival, retrieval, and destruction of GMP documents. Coordinate change controls, impact assessments, and approvals. Monitor SOP implementation and support sites during audits. Identify procedural gaps vs. global regulatory guidelines (ICH, WHO, 21 CFR). Maintain archives, QA stationary, and audit trails (eDMS). Conduct induction and cGMP training sessions. Support preparation for Management Review Meetings. Preferred candidate profile Strong knowledge of GMP & global regulatory guidelines Experience with eDMS/document control Good communication & coordination skills
Posted 1 month ago
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