Descripción de la oferta
Tecnico de Validación - Pharma RephineGijón, Asturias, gijón (comarca); principado de asturias, SpainDescripción del trabajoLeading Life Sciences Quality Worldwide 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. 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 next Computer System Validation Senior Consultant in Barcelona. As a CSV 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. 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. Perform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and global regulations. International Project Engagement: Contribute to projects across Spain, Europe, and China, adapting to diverse regulatory environments. Represent Rephine on-site with clients, ensuring seamless collaboration and delivering high-quality results. Project Delivery & Client Success: Manage timelines and ensure all deliverables, including documentation and test execution, are completed on schedule. Take a leading role in ERP validation projects while expanding your CSV expertise. A Bachelor’s degree in Chemistry or Engineering. Solid experience in the pharmaceutical industry, GxP compliance, and computerized systems validation. Strong multitasking skills and experience in managing multiple consulting projects to meet client needs. Fluency in Spanish and English, with excellent communication skills. Since client sites are often not easily accessible by public transportation, a valid driver’s license and willingness to travel by car are required. Take advantage of our hybrid work model, flexible hours, and a shorter workday on Fridays, allowing you to maintain a healthy balance between work and personal life. Global Exposure: Work with a multicultural team across multiple countries, providing opportunities to expand your professional network and gain international experience. Drive Digital Transformation: Participate in projects where you can use the latest technologies to optimize manufacturing and quality processes. For over 20 years, Rephine has been at the forefront of improving manufacturing quality processes for leading Life Sciences companies. Visit our career site to learn more and apply in English.
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