Description
This role involves ensuring compliance with global quality standards (FDA & EMA) and adhering to regulatory requirements like GxP/GMP, 21 CFR Part 11, and Annexes 11, 15, and 22. The individual will maintain and update computerized system lists, approve validation strategies, support technical report drafting, and contribute to business solutions meeting regulatory needs. Key responsibilities include providing support for validation documentation, assisting IT validation teams, verifying system validations, performing risk assessments, acting as a primary Q&A point for nonconformities, supporting quality processes, and participating in audits.
