Senior Executive - CQA CSV

About the role

To monitor, and execute end-to-end validation, qualification, and life cycle management of GxP-impacting computerized systems across USV Private Limited, ensuring continuous regulatory compliance, audit readiness, robust data integrity, and strict adherence to internal eQMS standards.

What you'll do

• Review / approve all CSV and CSA/qualification documentation across the system life cycle, using ValGenesis Validation Lifecycle Management System
• Audit & Inspection Management: Participate in internal, customer, and regulatory agency audits to explain computer system validation activities, strategies
• SOP & Policy Lifecycle Management: Drive continuous review, updates, and timely implementation of SOPs and policies related to GxP-impacting computerized systems to…
• Ensure core root cause analysis and corrective actions maintain a compliant state
• Periodic Reviews & Functional Assessments: Review, and approve periodic reviews of GxP-impacting computerized systems

What you need

• 5–8 yrs of experience
• Audit
• Technical writing
• Coordination
• SAP
• Root cause analysis
• PLC
• B.Tech or B.E. or M.Sc or B.Pharm or M.Pharm

Good to have

• SCADA
• ERP
• WMS
• FMEA
• SOP writing