Business Analyst – GxP, Computer System Validation

This is a fully remote position, open to applicants in United States, +2 more locations.

📋 Description

• Take charge of and manage the GxP validation package, which includes around 20 validation documents.

• Ensure the validation package is complete, consistent, and prepared for audits.

• Gather, analyze, and document both business and system requirements, such as URS, functional requirements, process flows, and requirements traceability.

• Categorize validation documents as either narrative or state-derived.

• Write narrative documents and maintain supporting evidence.

• Create and uphold validation documentation in line with GAMP 5, CSV, and GxP standards.

• Assist in and coordinate IQ/OQ/PQ validation processes, including test documentation, evidence gathering, review, and traceability.

• Conduct risk assessments, gap analysis, change control, and impact assessments.

• Keep validation evidence, traceability matrices, deviations, CAPA documentation, periodic reviews, and other compliance records up to date.

• Collaborate with business, IT, quality, and validation teams to ensure thorough regulatory and audit preparedness.

⛳️ Requirements

• Over 8 years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or a similar role within regulated environments.

• Proven experience in pharmaceutical, life sciences, or other GxP-regulated settings.

• Extensive experience in requirements elicitation, URS development, functional/business requirements, process mapping, and requirements traceability.

• Practical experience with Computer System Validation (CSV).

• In-depth understanding 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 in supporting regulatory audits and maintaining audit-ready validation evidence, including change controls, deviations, CAPA, and periodic reviews.

• Exceptional technical documentation and writing skills.

• Experience in managing controlled validation documentation and complete validation packages.

• Strong skills in stakeholder management, communication, analysis, and organization.

• Ability to work effectively across business, technical, quality, and compliance teams.

🏝️ Benefits

• Flexible remote work arrangement.

• Dynamic and flat work culture.

• Empowerment to take ownership of your work.

• Encouragement of open collaboration.

• Opportunity to make a significant impact.