Drive IT platform and application governance throughout the system development lifecycle, including design, development, release, change management, and retirement, ensuring regulatory compliance
Plan and execute Computer System Validation (CSV) and Computer Software Assurance (CSA) activities using risk-based GAMP 5 methodologies
Lead qualification activities for systems, platforms, cloud environments, and sandboxes, including IQ/OQ/PQ
Prepare and review validation documentation such as Validation Plans, Risk Assessments, URS, Functional Specifications, Traceability Matrices, Test Scripts, and Validation Summary Reports
Ensure compliance with GxP, 21 CFR Part 11, EU Annex 11, and applicable pharmaceutical regulatory standards
The Senior Product Owner - CSV is responsible for leading and managing Computer System Validation (CSV) activities to ensure digital systems are compliant, validated, and fit for purpose throughout their lifecycle. The role works closely with business, quality, validation, and technology teams to translate business and regulatory requirements into compliant solutions, validation strategies, and prioritized deliverables.
Responsibilities
Manage CSV requirements, validation deliverables, and compliance activities for MES systems.
Own and manage CSV requirements, validation activities, risk assessments, testing, change controls, and release readiness to ensure 100% compliance with GxP, data integrity, security, and regulatory requirements.
Ensure on-time delivery of validation documentation, test evidence, and approvals, maintain systems in a validated and audit-ready state throughout their lifecycle.
Drive audit and inspection readiness, minimizing compliance observations and ensuring timely closure of audit findings, deviations, CAPAs, and change controls.
Collaborate with business, quality, engineering, and site teams to deliver validated solutions that meet business objectives and regulatory expectations.
Requirements
Bachelor’s or master’s degree in computer science, Information Technology, Engineering, Business, Life Sciences or a related discipline
Nice to have: communication
Nice to have: facilitation
Nice to have: stakeholder management
Nice to have: requirements gathering
Bachelor's degree in Computer Science, Information Technology, Pharmaceutical Sciences, or a related field
Senior Tech Specialist, Cloud EngineeringBrillio · Bangalore, India+1 more