Validation Analyst

The Validation Analyst is responsible for planning, executing, and documenting validation activities to ensure compliance with regulatory requirements (FDA, EMA, GxP, HIPAA, SOX) and internal quality standards. This role supports Computer System Validation (CSV), equipment qualification, and process validation across the organization.<br /> <br /> <b>Key Responsibilities:</b><br /> Develop and maintain validation documentation including Validation Plans, Risk Assessments, IQ/OQ/PQ protocols, and Summary Reports.<br /> Perform Computer System Validation (CSV) activities in alignment with GAMP 5 and 21 CFR Part 11 guidelines.<br /> Ensure compliance with GxP, ICH Q9/Q10, and other applicable regulatory standards.<br /> Execute validation testing, record results, and manage deviations/CAPA as required.<br /> Collaborate with cross-functional teams (IT, QA, Manufacturing, R&D) for validation deliverables.<br /...