Act as SME for review Quality Incidents, Change Controls, CAPA;s and procedures for IT systems. Responsible for review/Approval of stand Alone/Enterprise GxP Computerized systems validation documents, including enhancements. Responsible for review/approval of IT infrastructure qualification documents, including enhancements. Author & review CS-VMP and associated protocols & report templates. Conduct trainings in the areas of (CSV SOPs and related topics) to develop in-house capability. Support audit/assessment of suppliers of GxP IT Computerized Systems as SME. Support Audit preparation and remediation activities, as appropriate. Responsible for Monthly Reporting, as applicable. Support IT Compliance/Data Management/Data Security & Data Integrity for GxP computerized systems. Conduct Self Inspections for IT Compliance, establish CAPA to correct deficiencies and ensure closeout. Coordinate with the cross functional team to ensure timely initiation and closure of all QMS activities Viz., Incident, CC, CAPAs, as applicable. Report and escalate issues, as situation demands. Perform other duties, as assigned.

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Quality Control Manager