GxP CSV Business Analyst — Regulated Validation

Nagarro; Poland; Remote; PLN 180,000 - 280,000; Full time

Job summary

Nagarro is seeking a skilled GxP CSV Business Analyst to ensure systems in regulated pharmaceutical and life-sciences environments are properly defined, validated, documented, and audit-ready. You will own the GxP validation package, translate regulatory requirements into clear validation documents, and maintain full traceability across the system lifecycle.

Work closely with business, IT, quality, and validation teams to ensure requirements, risks, testing, and change controls meet GxP and CSV

Qualifications

• 8+ years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or a related role within regulated environments.
• Strong experience with requirements elicitation, URS development, functional/business requirements, process mapping, and requirements traceability.
• Hands-on experience with Computer System Validation (CSV) and strong knowledge of GAMP 5 principles.
• Experience supporting regulatory audits and maintaining audit-ready validation evidence, including change controls, deviations, CAPA, and periodic reviews.

Responsibilities

• Own and coordinate the GxP validation package, consisting of approximately 20 validation 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 ensure appropriate supporting evidence is maintained.
• 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.

Skills

GxP validation

CSV (Computer System Validation)

Requirements elicitation

Stakeholder management

Technical documentation

Traceability

Audit readiness

Validation lifecycle

Tools

GAMP 5

Job description

Nagarro is seeking a skilled GxP CSV Business Analyst to ensure systems in regulated pharmaceutical and life-sciences environments are properly defined, validated, documented, and audit-ready. You will own the GxP validation package, translate regulatory requirements into clear validation documents, and maintain full traceability across the system lifecycle.

Work closely with business, IT, quality, and validation teams to ensure requirements, risks, testing, and change controls meet GxP and CSV