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pbJoin Rephine Barcelona: Leading Life Sciences Quality Worldwide /b /ppAt 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. /ppbr/ppbWho We're Looking For: /b /ppAre 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 bComputer System Validation Senior Consultant /b in Barcelona. /ppbr/ppbYour Role: /b /ppAs a bCSV L2 Consultant /b, 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. /ppbr/ppbKey Responsibilities: /b /ppbLead CSV Projects: /b /pulliTake ownership of ERP and other computerized system validations (IQ, OQ, PQ), preparing and reviewing critical documentation (VMP, URS, SOPs). /liliEnsure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines. /li /ulpbERP System Expertise: /b /pulliWork hands-on with ERPs, eDMS, eQMS, LIMS, laboratory systems, SCADA, EBRs, pharmacovigilance, and maintenance systems. /liliAssess system compliance and performance to optimize regulatory readiness and operational efficiency. /li /ulpbAudits Compliance Assessments: /b /pulliPerform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and global regulations. /liliIdentify risks, provide actionable recommendations, and ensure corrective measures are implemented. /li /ulpbInternational Project Engagement: /b /pulliContribute to projects across Spain, Europe, and China, adapting to diverse regulatory environments. /liliRepresent Rephine on-site with clients, ensuring seamless collaboration and delivering high-quality results. /li /ulpbProject Delivery Client Success: /b /pulliManage timelines and ensure all deliverables, including documentation and test execution, are completed on schedule. /liliMaintain clear communication with stakeholders and provide progress updates regularly. /li /ulpbWhy This Role Could Excite You: /b /pulliTake a leading role in ERP validation projects while expanding your CSV expertise. /liliWork with international teams and cutting-edge systems in a fast-paced consulting environment. /liliBe recognized as an L2 expert contributing to both client success and Rephine’s high standards. /li /ulpbr/ppbWhat You Bring: /b /pulliA Bachelor’s degree in Chemistry or Engineering. /liliSolid experience in the pharmaceutical industry, GxP compliance, and computerized systems validation. /liliStrong multitasking skills and experience in managing multiple consulting projects to meet client needs. /liliFluency in Spanish and English, with excellent communication skills. /liliSince client sites are often not easily accessible by public transportation, a valid driver’s license and willingness to travel by car are required. /li /ulpbr/ppbIs This Role for You? /b /ppAsk yourself: /pulliAre you excited about working with clients to tackle their most critical challenges? /liliCan you maintain a sense of ownership and connection to the Rephine team, even when managing demanding client-facing responsibilities? /liliDo you have the adaptability to move between technical tasks, regulatory compliance, and client interaction with ease? /liliAre you ready to learn and grow in a role that exposes you to a wide range of systems and industries? /li /ulpbr/ppIf 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. /ppbr/ppbWhy Choose Rephine? /b /ppWe believe in rewarding talent and commitment with a comprehensive benefits package designed to support your personal and professional growth: /pullibCompetitive Compensation: /b A salary that reflects your experience, along with additional vacation days and other benefits. /lilibWork-Life Balance: /b 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. /lilibGlobal Exposure: /b Work with a multicultural team across multiple countries, providing opportunities to expand your professional network and gain international experience. /lilibDynamic Work Environment: /b Join a young, enthusiastic team where your contributions are valued, and your ideas can shape the future of the company. /lilibFlexible Salary Options: /b Benefit from salary sacrifice schemes and more flexibility in managing your compensation package. /lilibOpportunities for Growth: /b 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. /lilibDrive Digital Transformation: /b Participate in projects where you can use the latest technologies to optimize manufacturing and quality processes. /li /ulpbr/ppFor 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. /ppbr/ppbReady to embark on this journey? /b /ppbr/ppVisit our career site to learn more and apply in English. /p

pSupports EMEA wide QA/RA operations, participating to EMEA QA/RA Management meetings, documenting EMEA policies, accompanying the Snr. Director QA/RA EMEA to perform quality visits to countries and issue gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions within the Global Distribution Group Henry Schein Sites in EMEA. /ppbr/ppActs as Technical Import Manager for Spain and is responsible in this role for ensuring that all imported medical products comply with strict European Union (EU) regulations and Spanish national laws (AEMPS). /ppbr/ppProvides support for coordinating the Henry Schein Brand registration and Henry Schein Products product launch activities in EMEA. Provides operational support Regulatory Affairs in Spain by facilitating regulatory document compliance according to different markets regulatory requirements and Henry Schein’s economic operator role as importer or distributor. /ppbr/ppbESSENTIAL DUTIES AND RESPONSIBILITIES: /b /ppbr/pulliSupports EMEA-wide QA/RA operations, documenting EMEA policies and provides support to implement the EMEA Quality Management System. /liliTo provide comprehensive managerial and strategic ensuring efficient daily operations, effective communication, and seamless regional management of quality-related projects, compliance, and reporting. /liliSupports to perform quality regulatory visits and /or audits to countries and issues gap analysis, ensures CAPA follow-up on identified issues and support countries in implementing solutions. /liliParticipates to EMEA QA/RA Management meetings, issues minutes and follows-up on decided actions with related functional / country QA/RA Lead. /liliOrganizing virtual, onsite, and offsite regional meetings, including logistics, agendas and close follow-up of identified actions. /liliDriving supporting multiple projects, tracking timelines, and ensuring successful outcomes for EMEA-wide QA/RA initiatives. /liliProvides support to the PRRC of the EC Rep in Germany for Henry Schein Products. /liliReview Quality Agreements to ensure responsibilities of economic operators (Importer/Distributor) are clearly addressed. /liliManaging post-market surveillance (PMS), handling reporting obligations (vigilance/incidents), and liaising with authorities, essentially guaranteeing product safety and compliance throughout its lifecycle on behalf of the PRRC. /liliProvides operational support to Regulatory Affairs by facilitating regulatory document compliance according to different markets regulatory requirements and Henry Schein’s economic operator role as importer or distributor to support HSPG product launch and registration activities in EMEA. /liliProvides support to the Spanish QA/RA Team for Quality related topics to ensure compliance according GDP and MDR. /liliall imported products have the required CE marking, declarations of conformity, and technical documentation required by EU Regulations 2017/745 (MDR) and 2017/746 (IVDR). /liliManage the prior operating license for importing and ensure products are registered on the CCPS portal (Spanish Medical Device Marketing Notification) and EUDAMED. /liliCoordinate with customs brokers to facilitate clearance, manage tariff codes, and handle documentation to prevent import delays. /liliVerify that imported products meet quality standards and specifications, including proper labeling and translation of instructions for use (IFU) for the Spanish market. /liliAct as the technical contact for monitoring products after they are placed on the market, collecting data, and reporting incidents to the Spanish Authorities. /li /ulpbr/ppbQUALIFICATIONS: /b /ppbr/ppbExperience: /b /ppbr/pulliQuality Management, Project Management experiences, Medical Device Experiences, Pharmaceutical (GDP) experience is a plus /liliSupport Communicating with Regulatory Bodies /liliMDR /IVDR Regulations/ ISO 13485 /liliValidation of (computerized systems) and Risk management (FMEA) knowledge is a plus /li /ulpbr/ppbEducation: /b /ppbr/pulliBachelor’s degree in Life Sciences, Pharmacist, Biomedical Engineering, or a related field. /li /ulpbr/ppbSpecialised Knowledge and Skills: /b /ppbr/pulliKnowledge and understanding of Quality Management and Project Management /liliQuality System process implementation and maintenance to meet ISO 13485:2016; GDP and MDR. /liliSolution oriented, problem-solving attitude, pragmatic, high adaptability and flexibility /liliAbility to work in a matrix, regional environment with different departments and countries /liliEnglish speaker /liliGood communication skills and stakeholder management /li /ulpbr/ppbOther: /b /ppbr/pulliBalances a sense of urgency of time pressures with adherence to all regulatory requirements. /liliSensitive in dealing with confidential Information /liliDemonstrates advanced oral and written communication skills /liliMust be fluent in written and spoken English /li /ul

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