Business Analyst – GxP & Computer System Validation

Nagarro is a digital product engineering company with over 18,000 experts across 39 countries, specializing in scalable products, services, and experiences.

• 8+ years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or related roles in regulated environments.
• Experience in pharmaceutical, life-sciences, or other GxP-regulated environments.
• Strong skills in requirements elicitation, URS development, functional/business requirements, process mapping, and requirements traceability.
• Hands-on experience with Computer System Validation (CSV) and knowledge of GAMP 5 principles.
• Knowledge of validation documentation and lifecycle activities, including URS/FS/DS, IQ/OQ/PQ, risk assessment, validation strategy, and test documentation.
• Experience supporting regulatory audits and maintaining audit-ready validation evidence, including change controls, deviations, CAPA, and periodic reviews.
• Excellent technical documentation and authoring skills managing controlled validation documentation and complete validation packages.
• Strong stakeholder management, communication, analytical, and organizational skills to work across business, technical, quality, and compliance teams.

• Own and coordinate the GxP validation package of approximately 20 documents ensuring completeness, consistency, and audit readiness.
• Elicit, analyze, and document business and system requirements, including URS, functional requirements, process flows, and requirements traceability.
• Classify validation documents as narrative or state-derived, author narrative documents, and maintain supporting evidence.
• Develop and maintain validation documentation in accordance with GAMP 5, CSV, and GxP requirements.
• Support and coordinate IQ/OQ/PQ validation activities, including test documentation, evidence collection, review, and traceability.
• Perform risk assessments, gap analysis, change control, and impact assessments related to validated systems and processes.
• Maintain validation evidence, traceability matrices, deviations, CAPA documentation, periodic reviews, and other compliance records.
• Collaborate with stakeholders across business, IT, quality, and validation teams to ensure end-to-end regulatory and audit readiness.