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8.0 - 13.0 years
8 - 14 Lacs
ahmedabad
Work from Office
Responsibilities: Lead quality assurance activities, including gap assessments & extended CAPAs. Ensure regulatory audit readiness with US FDA & EMA compliance. Manage audit compliance process from planning to closure.
Posted 1 month ago
4.0 - 8.0 years
5 - 11 Lacs
ahmedabad
Work from Office
Summary Job Functions: Audit and Compliance, Quality Technical Agreement, Gap Assessment, Extended CAPA Key Responsibilities: - Drive the self-inspection program at Intas-Biopharma site. Ensure the self-inspection program run as per defined schedule. - Perform risk assessment to determine the frequency of the self- inspection. Ensuring the appropriate CAPAs are identified and implemented in appropriately. - Management of external quality audits. Responsible to facilitate for the management of backroom, coordinate the auditors request, works as scribe during audit, preparation of response etc 4. Tracking and follow up of internal and external audit CAPA. - Verification of CAPA effectiveness o...
Posted 1 month ago
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