Senior CSV Consultant — Global ERP Validation & Compliance

Rephine

Santander

Presencial

EUR 50.000 - 75.000

Jornada completa

Hace 2 días

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Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Flexible hours

Global exposure

Descripción de la vacante

Rephine busca un Consultor CSV Senior para Barcelona, liderando proyectos de validación ERP y sistemas computarizados en entornos regulados. Participarás en auditorías, revisión de documentación y aseguramiento de cumplimiento, trabajando con equipos internacionales.

El rol exige experiencia en GxP, comunicación fluida en español e inglés y disponibilidad para viajar. Ofrecemos un entorno dinámico, modelo híbrido y crecimiento profesional en una empresa global.

Formación

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.

Responsabilidades

Lead CSV Projects: ownership of ERP and other computerized system validations (IQ, OQ, PQ); prepare and review documentation (VMP, URS, SOPs).
Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity guidelines.
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.
Perform supplier audits and compliance checks, focusing on Annex 11, 21 CFR Part 11, and global regulations.
Identify risks, provide actionable recommendations, and ensure corrective measures are implemented.
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.
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.