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
Experience:- 7 10+ years of experience in Computer System Validation (CSV)
- Experience in Pharmaceutical / Biotechnology / Medical Device industry
Skills
Biotech and Pharmaceuticalunmatched
Cloud Computingunmatched
Computer Skillsunmatched
Computer Systemsunmatched
Data Migrationunmatched
ERP (Enterprise Resource Planning)unmatched
FDA Requirementsunmatched
GxPunmatched
Leadershipunmatched
Maintain Complianceunmatched
Medical Equipmentunmatched
Process Validationunmatched
Riskunmatched
Standard Operating Procedures (SOP)unmatched
System Validationunmatched
Traceabilityunmatched
Validation Documentationunmatched
Validation Planunmatched
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