Business Analyst – GxP & Computer System Validation

Nagarro is seeking a skilled GxP CSV Business Analyst to ensure that systems and processes within regulated pharmaceutical and life-sciences environments are properly defined, validated, and audit-ready. You will play a pivotal role in coordinating validation packages and translating complex regulatory requirements into clear, compliant documentation.

Key responsibilities

• Own and coordinate the GxP validation package, ensuring completeness, consistency, and audit readiness across all documentation.
• Elicit, analyze, and document business and system requirements, including URS, functional requirements, and process flows.
• Develop and maintain validation documentation in strict accordance with GAMP 5, CSV, and GxP regulatory standards.
• Support and coordinate IQ/OQ/PQ validation activities, including test documentation, evidence collection, and traceability.
• Perform risk assessments, gap analysis, and manage change controls to ensure end-to-end regulatory compliance.

Requirements

• 8+ years of experience in Business Analysis, Computer System Validation, or related roles within regulated environments.
• Proven experience working in pharmaceutical, life-sciences, or other GxP-regulated sectors.
• Strong knowledge of GAMP 5 principles and the full Computer System Validation lifecycle.
• Expertise in technical documentation, including URS, FS, DS, and validation strategy development.
• Excellent stakeholder management skills with the ability to collaborate effectively across business, IT, and quality teams.

What we offer

• Opportunity to work with a global digital product engineering company with a presence in 39 countries.
• A dynamic, non-hierarchical work culture that empowers employees to take ownership and create meaningful impact.
• Engagement in large-scale projects that build innovative products and digital experiences.