Validation Manager (Contractor)
Greater NYC Area
5 hours ago
Develop and manage GxP system lifecycle documentation including Validation Plans, Testing Protocols (IQ,OQ,PQ), User Acceptance Testing, Traceability Matrix, Validation Reports, SOPs, Change Control Documentation and Risk Management Reports.
Develop/write test scripts and plans to ensure software functions as expected.
Lead and manage the compliance status and validation activities of computerized systems in accordance with current regulatory requirements.
Minimize business risk associated with the processing and storage of electronic documentation ensuring continuity over the system /product lifecycle.
Support and execute against validation strategic plan which delivers compliant systems that are cost effective with long term sustainable components.
Develop and manage KPIs for CSV and manage the scheduling of all validation activities within the business.