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10.0 - 15.0 years
10 - 14 Lacs
sangareddy, patancheru, hyderabad
Work from Office
Role & responsibilities Harmonize QA SOPs and formats of MSN API divisions into corporate procedures in line with global regulatory guidelines (ICH, 21 CFR, EU, WHO). Prepare and distribute CQA SOPs and formats to respective manufacturing sites. Ensure timely initiation and closure of change controls, including impact assessments and approvals by relevant departments and Head CQA. Monitor the implementation of established procedures across API manufacturing sites. Provide QA support during regulatory inspections at sites, as needed. Manage document control activities, including issuance, archival, retrieval, and retention of GMP documents. Issue GMP-related registers and reconcile records ac...
Posted 1 month ago
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