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Job Description
At Rephine, we set the standard for quality assurance and GxP compliance in the Life Sciences industry. With offices in Barcelona, the UK, and China, India, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally.
Role Overview
We are looking for a Computer System Validation Senior Consultant in Barcelona. As a CSV L2 Consultant, you will take an active role in delivering highโimpact validation projects, with a focus on ERP systems and other critical computerized systems in regulated environments. You will be part of innovative projects, ensuring compliance, efficiency, and quality across the lifecycle.
Responsibilities
- Lead CSV projects: Take ownership of ERP and other computerized system validations (IQ, OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs). Ensure compliance with EU GMP Annex11, FDA21CFRPart11, GAMP5, and Data Integrity guidelines.
- ERP & system expertise: Work handsโon w...