Business Analyst – GxP, Computer System Validation

Job not on LinkedIn

🔥 0 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧐 Business Analyst

🦅 H1B Visa Sponsor

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Nagarro

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1996

💼 Consulting

📣 Marketing

🏥 Healthcare

Consulting • Marketing • Healthcare

Nagarro is a global leader in digital engineering and technology consulting. The company helps clients become innovative, digital-first businesses by leveraging technology to drive business breakthroughs. Known for its entrepreneurial agility and CARING mindset, Nagarro offers a wide range of services, including digital engineering, intelligent enterprise solutions, and experience and design services. With over 17,900 employees across 37 countries, Nagarro collaborates with industry leaders to accelerate digitalization and technology-led innovation.

📋 Description

• Own and coordinate the GxP validation package of approximately 20 validation documents • 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 according to 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 for validated systems and processes • Maintain validation evidence, traceability matrices, deviations, CAPA documentation, periodic reviews, and other compliance records • Collaborate with business, IT, quality, and validation teams to ensure regulatory and audit readiness

🎯 Requirements

• 8+ years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or a related role within regulated environments • Experience working in pharmaceutical, life-sciences, or other GxP-regulated environments • Experience with requirements elicitation, URS development, functional/business requirements, process mapping, and requirements traceability • Hands-on experience with Computer System Validation (CSV) • Strong 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 • Technical documentation and authoring skills • Experience managing controlled validation documentation and complete validation packages • Stakeholder management, communication, analytical, and organizational skills • Ability to work across business, technical, quality, and compliance teams

🏖️ Benefits

• Remote work options • Dynamic, non-hierarchical work culture • Employee ownership and open collaboration • Opportunity to create meaningful impact • Work with global teams across 39 countries