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, India, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally.
Descubra exactamente qué habilidades, experiencia y cualificaciones necesitará para tener éxito en este puesto antes de enviar su solicitud a continuación.
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). 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.
* Audits & Compliance Assessments: Perform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and integral regulations. Identify risks, provide actionable recommendations, and ensure corrective measures are implemented.
* 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. Maintain clear communication with stakeholders and provide progress updates regularly.
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.
* Valid driver’s license and willingness to travel by car, as client sites may not be accessible by public transportation.
Is This Role for You?
Ask yourself: Are you excited about working 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?
Why Choose Rephine?
* Competitive Compensation: A salary that reflects your experience, along with additional vacation days and other benefits.
* Work‑Life Balance: Hybrid work model, flexible hours, and a shorter workday on Fridays.
* Global Exposure: Work with a multicultural team across multiple countries, expanding your professional network.
* Dynamic Work Environment: A young, enthusiastic team where your contributions are valued.
* Flexible Salary Options: Salary sacrifice schemes and other flexibility in managing your compensation package.
* Opportunities for Growth: A nurturing environment for career development.
* Drive Digital Transformation: Participate in projects that 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.
#J-18808-Ljbffr