Business Analyst – GxP & Computer System Validation

Description

As a GxP CSV Business Analyst, your mission is to ensure that systems and processes operating within regulated pharmaceutical and life-sciences environments are properly defined, validated, documented, and audit-ready. You will own and coordinate the GxP validation package, translate business and regulatory requirements into clear validation documentation, and ensure full traceability and compliance throughout the system lifecycle.

You will work closely with business stakeholders, technical teams, quality teams, and validation experts to ensure that requirements, risks, testing, documentation, and change controls meet GxP and Computer System Validation standards.

• 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 readines

• 8+ years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or a related role within regulated environments.
• Demonstrable experience working in pharmaceutical, life-sciences, or other GxP-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.
• Strong 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, with experience managing controlled validation documentation and complete validation packages.
• Strong stakeholder management, communication, analytical, and organizational skills, with the ability to work effectively across business, technical, quality, and compliance teams.

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