Business Analyst (GxP & Computer System Validation)

Location: Remote, Poland; Service Region: Eastern Europe

Company

hirify.global is a digital product engineering company delivering products, services, and digital experiences through a global organization of more than 18,000 experts across 39 countries.

What you will do

• Own and coordinate a GxP validation package of approximately 20 documents, maintaining completeness, consistency, and audit readiness.
• Elicit, analyze, and document business and system requirements, including URS, functional requirements, process flows, and traceability.
• Classify and author validation documents, maintaining supporting evidence and controlled documentation.
• Develop validation documentation in line with GAMP 5, Computer System Validation, and GxP requirements.
• Coordinate IQ/OQ/PQ activities, including test documentation, evidence collection, review, and traceability.
• Perform risk assessments, gap analyses, change controls, impact assessments, and maintain deviations, CAPA records, and periodic reviews.

Requirements

• 8+ years of experience in Business Analysis, Computer System Validation, or a related role in regulated environments.
• Experience in pharmaceutical, life-sciences, or other GxP-regulated environments.
• Strong skills in requirements elicitation, URS development, functional and business requirements, process mapping, and requirements traceability.
• Hands-on Computer System Validation experience and strong knowledge of GAMP 5.
• Knowledge of URS/FS/DS, IQ/OQ/PQ, validation strategies, risk assessments, and test documentation.
• Experience supporting regulatory audits and maintaining audit-ready evidence, with strong technical documentation and stakeholder-management skills.

Culture & Benefits

• Remote work from Poland within the Eastern Europe service region.
• Dynamic, non-hierarchical working environment with ownership and open collaboration.
• Cross-functional collaboration with business, IT, quality, compliance, and validation teams.