Join Rephine Barcelona: Leading Life Sciences Quality WorldwideHaga clic en "Solicitar" a continuación para enviar su candidatura. Asegúrese de que su CV está actualizado y de que ha leído primero las especificaciones del puesto.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.Who We're Looking For:Are you passionate about consulting in the Pharma and Life Sciences sector? Do you thrive in dynamic environments, eager to take on multiple projects and drive real impact? If you're excited by the challenge of enhancing quality and compliance in a global company, we want you as our nextComputer System Validation Senior Consultantin Barcelona.Your Role:As aCSV L2 Consultant , you will take an active role in delivering high-impact 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.Key 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 Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.ERP & System Expertise:Work hands-on with ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADA, EBRs, pharmacovigilance, and maintenance systems.Assess system compliance and performance to optimize regulatory readiness and operational efficiency.Audits & Compliance Assessments:Perform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and general regulations.Identify risks, provide actionable recommendations, and ensure corrective measures are implemented.International Project Engagement:Contribute to projects across Spain, Europe, and China, ada

📌 Computer System Validation Consultant (Barcelona)
🏢 MindMatch
📍 Barcelona