Computer System Validation- CSV

JD

Key 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 modern 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.

Required Qualifications

• Experience with GxP-regulated systems and computer system validation.
• Working knowledge of GAMP 5, CSA, data integrity, and risk-based validation.
• Experience with validation documentation, traceability, testing, deviations, change management, and audit readiness.
• Experience working with SaaS, cloud-hosted applications, or qualified cloud infrastructure.
• Strong stakeholder coordination, documentation, and delivery-management skills.
• Understanding of pharmacovigilance systems and related workflows.

Preferred Qualifications

• Hands-on experience with ServiceNow and ValGenesis.
• Experience with eLearning or learning-management platforms.
• Experience developing training materials and authoring eLearning content

Interested can drop your CV to [email protected]