USI-Argenx/Eli Lilly-Computer System Validation-GxP

Description <p data-ogsc=""> </p> <p data-ogsc="">Owns validation approach, risk assessment, scope, and testing strategy using GAMP 5 / CSA principles to ensure effort is focused on patient safety, product quality, and data integrity.</p> <p data-ogsc="">Manages validation deliverables, deviations, change control, CAPA support, traceability, and audit readiness to maintain the validated state of regulated systems.</p> <p data-ogsc="">Applies GxP expectations, GAMP 5 , and CSA guidance across traditional, agile, and modern digital platforms, including knowing when supplier documentation can be leveraged</p> <p data-ogsc="">Oversees validation of SaaS and cloud-hosted applications, including vendor assessment, shared-responsibility understanding, release impact review, and use of supplier evidence and quality agreements.</p> <p data-ogsc="">Ensures controls arou...