Life Sciences : Computer System Validation

Key Responsibilities

• Plan, execute, and maintain Computer System Validation (CSV) activities for GxP-relevant computerized systems.
• Develop and review validation deliverables including Validation Plans, User Requirements, Risk Assessments, Test Protocols, Test Scripts, Traceability Matrices, and Validation Summary Reports.
• Ensure validation activities demonstrate that systems are fit for intended use, reliable, and operating within a controlled environment.
• Apply risk-based validation principles aligned with regulatory expectations such as GxP, 21 CFR Part 11, and ISO 13485.
• Support audits and inspections by providing complete, clear, and compliant validation documentation.
• Assess the impact of system changes and support revalidation activities when required.
• Ensure validated systems remain in a compliant state through effective change control and configuration management.
• Review system updates, patches, and enhancements to determine their validation impact.
• Maintain system inventory and validation status throughout the system lifecycle.
• Work closely with IT, Quality, Engineering, Vendors, and Business stakeholders to support validation activities.
• Participate in system implementation projects and ensure validation requirements are incorporated from the early lifecycle stages.
• Provide training and awareness on CSV processes and regulatory expectations.
• Provide consultation to project teams on appropriate software validation approaches.
• Recommend suitable validation approaches based on project requirements and selected software validation methodology.
• Guide project teams in creating validation deliverables, SOPs, and Work Instructions.
• Provide consultation on regulatory compliance requirements including PI/PHI and Electronic Records and Electronic Signatures (21 CFR Part 11).
• Provide consultation on software change management and validation requirements.
• Review and approve validation deliverables and system changes.

Required Skills & Experience

• Strong experience in Computer System Validation (CSV) and Computer Software Assurance (CSA).
• Understanding of Software Development Life Cycle (SDLC) and its various phases.
• Strong understanding of Risk Management principles, including ICH Q9 and ICH Q8.
• Good understanding of GAMP categories and validation methodologies.
• Understanding of industry standards such as ISO 13485.
• Knowledge of Quality Management Systems (QMS) and regulations such as 21 CFR Part 820.
• Understanding of SDLC methodologies and related implementation procedures.
• Hands-on experience in preparing and implementing CSV deliverables.
• Experience providing consultation on software validation approaches.
• Understanding of SOPs and Work Instructions and ability to guide project teams in their preparation.
• Knowledge of regulatory compliance requirements including PI/PHI and 21 CFR Part 11.
• Strong understanding of change management processes and software change validation.
• Experience reviewing and approving validation deliverables and system changes.