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CSV Lead

Katalyst CRO

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 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 710+ years of experience in Computer System Validation (CSV) Experience in Pharmaceutical / Biotechnology / Medical Device industry #J-18808-Ljbffr Katalyst CRO

Vacancy posted 18 hours ago
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