Computer System Validation Consultant
3 days ago
Sallent
Join Rephine Barcelona: Leading Life Sciences Quality Worldwide Por favor, presente su candidatura sin demora si su perfil encaja bien con este puesto, debido al alto nivel de interés. 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 next Computer System Validation Senior Consultant in Barcelona. Your Role: 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. 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)., • Work hands-on with ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADA, EBRs, pharmacovigilance, and maintenance systems., • Perform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and global regulations., • Contribute to projects across Spain, Europe, and China, adapting to diverse regulatory environments., • 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., • Work with international teams and cutting-edge systems in a fast-paced consulting environment., • 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. Ask yourself: • Are you excited about working on-site with clients to tackle their most critical challenges?, • Can you maintain a sense of ownership and connection to the Rephine team, even when managing demanding client-facing responsibilities?, • Do you have the adaptability to move between technical tasks, regulatory compliance, and client interaction with ease? Why Choose Rephine? We believe in rewarding talent and commitment with a comprehensive benefits package designed to support your personal and professional growth: • Competitive Compensation: A salary that reflects your experience, along with additional vacation days and other benefits., • Work-Life Balance: 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., • Dynamic Work Environment: Join a young, enthusiastic team where your contributions are valued, and your ideas can shape the future of the company., • Flexible Salary Options: Benefit from salary sacrifice schemes and more flexibility in managing your compensation package., • Opportunities for Growth: We provide a nurturing environment where your career can grow beyond expectations. Whether you're looking for new challenges or leadership opportunities, Rephine is committed to your continuous development. Ready to embark on this journey? xcskxlj Visit our career site to learn more and apply in English.