Company:IT Services Organization
Key Skills: CSV (computer system validation), xP Validation Practices, GxP compliance,
Roles and Responsibilities:
Own the validation approach, risk assessment, scope, and testing strategy using GAMP 5 and Computer Software Assurance principles, focusing effort on patient safety, product quality, and data integrity.
Lead validation lifecycle activities for GxP-regulated systems, including requirements, specifications, traceability, testing, deviations, change control, CAPA support, and audit readiness.
Apply GxP expectations, GAMP 5, and CSA principles across traditional, agile, SaaS, cloud-hosted, and contemporary digital platforms.
Determine when supplier documentation and testing evidence may be leveraged based on risk, intended use, vendor assessment, release impact, and quality arrangements.
Oversee SaaS and cloud validation activities, including shared-responsibility assessments, infrastructure qualification, release management, and maintenance of the validated or qualified state.
Assess data integrity controls, including audit trails,



user access, ALCOA+ principles, data lineage, interfaces, manual processes, and connected systems.
Support validation of AI/ML-enabled systems by considering intended use, data quality, explainability, human oversight, drift monitoring, and revalidation triggers.
Apply knowledge of pharmacovigilance processes, system workflows, regulatory expectations, and supporting documentation to validation lifecycle activities.
Coordinate validation activities across applications and systems, drive stakeholder follow-ups, and maintain schedules, dependencies, and deliverables.
Support IQ/OQ execution, user story development, test planning, training development, and content authoring.
Provide project and operational support for eLearning platforms, including understanding their implementation, integration, maintenance, and sustainability challenges.
Skills Required:
Experience with GxP-regulated systems and compute

📌 Computer System Validation_103103 (Bengaluru)
🏢 MyCareernet
📍 Bengaluru