Specific activities and responsibilities:
Plan, coordinate, and execute Computerized System and SW applications Validation (CSV) activities for client projects in compliance with GAMP 5, GMP, EU GMP Annex 11, and 21 CFR Part 11 requirements.Prepare, review, and manage validation documentation, including Validation Plans, Risk Assessments, URS, IQ/OQ/PQ protocols, and Validation Reports.Support clients in ensuring Data Integrity compliance in accordance with ALCOA+ principles and applicable regulatory requirements.Perform risk assessments to define validation strategies and support regulatory compliance.Support Change Control, Deviations, CAPAs, periodic reviews, and validation lifecycle activities for computerized systems.Collaborate with cross-functional client teams (QA, IT, Engineering, Manufacturing, QC, and Validation) to deliver validation projects.Assess the impact of software ...