Business Analyst – GxP, Computer System Validation

This is a fully remote position, open to applicants in Pennsylvania.

📋 Description

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

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

• Gather, analyze, and document business and system requirements, including URS, functional requirements, process flows, and traceability of requirements.

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

• Create narrative documents while maintaining the necessary supporting evidence.

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

• Assist and coordinate IQ/OQ/PQ validation efforts, encompassing test documentation, evidence collection, reviews, and traceability.

• Conduct risk assessments, gap analyses, change controls, and impact evaluations.

• Maintain validation evidence, traceability matrices, deviations, CAPA documentation, periodic reviews, and other compliance records.

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

⛳️ Requirements

• Over 8 years of experience in Business Analysis, Computer System Validation, or a similar role in regulated settings.

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

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

• Practical experience with Computer System Validation (CSV).

• In-depth knowledge of GAMP 5 principles.

• Robust understanding 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 comprehensive validation packages.

• Strong skills in stakeholder management, communication, analytical thinking, and organization.

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

🏝️ Benefits

• Opportunities for remote work.

• A dynamic and non-hierarchical workplace culture.

• Empowerment of employees and chances for ownership.

• An environment that encourages open collaboration.

• The chance to make a significant impact.

• Work alongside a global team spanning 39 countries.