Business Analyst – GxP, Computer System Validation

🔥 2 minutes ago

🔔 Pennsylvania – Remote

🔔 Pennsylvania – Remote

⏰ Full Time

🟠 Senior

🔴 Lead

🧐 Business Analyst

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 10%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

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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, consisting of approximately 20 validation documents • Ensure validation package 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 business, IT, quality, and validation teams to ensure end-to-end regulatory and audit readiness

🎯 Requirements

• 8+ years of experience in 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) • 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 • Experience managing controlled validation documentation and complete validation packages • Strong stakeholder management, communication, analytical, and organizational skills • Ability to work effectively across business, technical, quality, and compliance teams

🏖️ Benefits

• Remote work arrangement • Full-time employment