Lead Corporate Quality Assurance (CQA) activities for API manufacturing units and ensure compliance with cGMP and global regulatory requirements
Review and monitor QMS activities including deviations, CAPA, change controls, OOS/OOT, and investigations
Ensure compliance with USFDA, MHRA, WHO, and other regulatory standards across API sites
Drive quality systems implementation, data integrity practices, and continuous quality improvement initiatives
Review and approve SOPs, quality documents, protocols, and validation-related activities
Support and lead internal, customer, and regulatory audits, ensuring audit readiness across locations
Monitor site compliance, identify quality gaps, and implement corrective and preventive actions
Coordinate with QA, QC,
Production, and cross-functional teams for quality and compliance-related matters
Provide guidance and mentoring to site QA teams and support capability development initiatives
Ensure effective corporate oversight of quality systems and compliance performance across API units.
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