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Computer System Validation Consultant – Spain

hace 3 meses


Barcelona, España Rephine Limited A tiempo completo

.**About the Job at Rephine Barcelona: The Gold Standard in Life Sciences Quality**At Rephine, we pride ourselves on being the benchmark for product quality in the Life Sciences industry. We are a global authority in quality assurance and GxP compliance, supporting the Pharmaceutical, Biotech, and Medical Device manufacturing supply chains. With our roots firmly planted in Barcelona, Spain, Rephine has grown to include offices in the UK (Stevenage) and China (Shanghai), embodying a truly global presence.**Who We're Looking For:**Are you deeply passionate about Pharma and Life Sciences? Do you excel in team environments? Are you eager to learn and grow, managing multiple consulting projects, and making a tangible difference in a global company? If so, we're looking for someone like you to fill the role of a Computer System Validation Senior Consultant in our vibrant Barcelona team.**Your Mission Should You Choose to Accept:**As a part of our elite team, you'll embark on key projects worldwide, focusing on:- GxP Readiness: Enhancing quality and compliance throughout product development and manufacturing lifecycle.- Innovative Design Review:** Overseeing new facilities' design, equipment commissioning, and qualification.- Digital Transformation:** Leading the charge in manufacturing quality process optimization through cutting-edge technology.- Medical Device Excellence:** Navigating the regulatory landscape of smart devices and health apps.- Quality Management Systems:** Implementing and advising on QMS design and maintenance, including deployment of TrackWise Digital QMS.**Your Role and Responsibilities:**- Directly report to the CSV Area Manager:- Lead and collaborate on GxP compliance and Computerized Systems Validation projects.- Guide validation activities, oversee project execution, and ensure timely delivery of validation deliverables.- Manage and plan resources, leading a team of consultants to achieve project milestones.- Maintain constant communication with clients and the Area Manager regarding project status and deliverables.**Your Team:**Joining Rephine means becoming part of a team committed to excellence and continuous growth. Our consultants' involvement, experience, and expertise are our greatest assets, and we're looking for someone eager to contribute to our dynamic and supportive environment.**This Job Is for You If You Have:**- A Bachelor's degree in chemistry or engineering.- Experience in the pharmaceutical environment, GxP compliance, and computerized systems validation.- A knack for multitasking and managing multiple projects in alignment with client needs.- Willingness to travel and excellent communication skills in both Spanish and English.- A car for travel purposes.**Why Choose Rephine?**Competitive Compensation:Enjoy a salary that matches your experience, extra vacation days, and more.Work-Life Balance: Benefit from a hybrid work mode, flexible hours, and a reduced workday on Fridays