Job Description
Roles & Responsibilities:- Manage end-to-end validation lifecycle (Inventory, Assessment, Remediation, Final Disposition).
- Perform ERP validation, Data Migration, and Cloud Validation activities.
- Prepare and review validation documentation (Validation Plans, IQ/OQ/PQ, Traceability Matrix, Reports, SOPs).
- Ensure compliance with GxP, FDA regulations, and risk-based validation.
- Support Acquisitions, Divestitures, and Business Separation projects.
- Demonstrate strong leadership and stakeholder communication.
Requirements:- 7 10+ years of experience in Computer System Validation (CSV).
- Experience in Pharmaceutical / Biotechnology / Medical Device industry.