Roles and Responsibilities:
Lead end-to-end Computer System Validation for GxP systems. Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports. Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP. Manage validation risk and maintain systems in a validated state. Collaborate with IT, QA, Labs, and vendors.
Lead end-to-end Computer System Validation for GxP systems. Develop and review URS, risk assessments, IQ/OQ/PQ protocols, and validation reports. Ensure compliance with FDA 21 CFR Part 11, GAMP 5, and GxP. Manage validation risk and maintain systems in a validated state. Collaborate with IT, QA, Labs, and vendors.