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Computer System Validation Senior Consultant
hace 2 semanas
Join Rephine Barcelona: Leading 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, 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 Senior Consultant , you will take the lead in delivering impactful projects in compliance and validation, contributing to some of the most innovative areas in the industry. Your key responsibilities will include: Driving Excellence in CSV Projects: Participate in and oversee projects involving the validation of computerized systems across the project lifecycle, including the preparation of critical documentation (e.g., VMP, URS, IQ, OQ, PQ). Ensure strict adherence to industry regulations, including EU GMP Annex 11 , FDA 21 CFR Part 11 , GAMP 5 , and Data Integrity guidelines. Exploring Advanced Industry Systems: Work with and gain exposure to widely used systems, including ERPs , eDMS , eQMS , LIMS , laboratory systems, SCADAs , EBRs , pharmacovigilance, and maintenance systems. Assess system compliance with global standards to ensure efficiency and regulatory readiness. Auditing and Compliance Assessments: Perform audits of software suppliers to verify adherence to Annex 11, 21 CFR Part 11, and other regulatory frameworks. Provide expert assessments of compliance risks and propose actionable solutions. Engaging in International Projects: Contribute to projects across Spain , Europe , and China , bringing your expertise to clients in diverse regulatory environments. Represent Rephine’s values while working on-site with clients, ensuring seamless collaboration and delivering quality results. Meeting Deadlines and Driving Client Success: Manage project timelines, ensuring deliverables like documentation and test execution are completed as agreed with the client. Maintain clear communication and provide regular updates on progress to stakeholders. What You Bring: 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. Is This Role for You? 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? Are you ready to learn and grow in a role that exposes you to a wide range of systems and industries? If your answer is "yes" to these questions, then this opportunity at Rephine is your chance to make a significant impact while growing your career in CSV consulting. 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. 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. We’re evolving rapidly and looking for passionate professionals eager to grow with us. Ready to embark on this journey? Visit our career site to learn more and apply in English.
