4 дня назад
Business Analyst (GxP & Computer System Validation)
Вакансия из Hirify Global, списка международных tech-компанийДля мэтча и отклика нужен Plus
Мэтч & Сопровод
Для мэтча с этой вакансией нужен Plus
Описание вакансии
Текст:
TL;DR
Business Analyst (GxP & Computer System Validation) (GxP/CSV): Defining, validating, and documenting systems and processes in regulated pharmaceutical and life-sciences environments with an accent on requirements traceability, validation documentation, and audit readiness. Focus on coordinating IQ/OQ/PQ activities, performing risk and impact assessments, and maintaining complete validation evidence across the system lifecycle.
Location: Remote, Poland; service region: Eastern Europe
Company
is a digital product engineering company delivering products, services, and experiences through a global network of more than 18,000 experts across 39 countries.
What you will do
- Own and coordinate an approximately 20-document GxP validation package, ensuring completeness, consistency, and audit readiness.
- Elicit and document business and system requirements, including URS, functional requirements, process flows, and traceability.
- Classify and author validation documents and maintain supporting evidence in line with GAMP 5, CSV, and GxP requirements.
- 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, deviations, CAPA documentation, periodic reviews, and other compliance records while collaborating with business, IT, quality, and validation stakeholders.
Requirements
- 8+ years of experience in Software/Data Engineering, Business Analysis, Computer System Validation, or a related role in regulated environments.
- Experience in pharmaceutical, life-sciences, or other GxP-regulated environments.
- Strong experience with 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 principles.
- Knowledge of URS/FS/DS, IQ/OQ/PQ, risk assessment, validation strategy, and test documentation.
- Experience supporting regulatory audits and maintaining controlled, audit-ready validation evidence, including change controls, deviations, CAPA, and periodic reviews.
Culture & Benefits
- Remote work from Poland within the Eastern Europe service region.
- Collaboration across business, technical, quality, compliance, and validation teams.
- Dynamic, non-hierarchical work culture with employee ownership and open collaboration.
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