Senior CSV Consultant - ERP Validation & GxP Expert

Rephine; Sevilla; Híbrido; EUR 65.000 - 95.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Hybrid work model

Global exposure

Career development

Dynamic team

Flexible salary options

Descripción de la vacante

Rephine Seville in Andalusia, Spain, is seeking a Computer System Validation Senior Consultant to lead ERP and critical computerized system validations in regulated environments. You will own IQ/OQ/PQ activities, review key documents, and drive compliance with EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5 while collaborating with international teams.

Travel to client sites across Spain and Europe is expected, with on-site engagements in Barcelona and Seville, and occasional visits to China.

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 managing multiple consulting projects.
• Fluency in Spanish and English with excellent communication skills.

Responsabilidades

• Lead CSV projects including IQ, OQ, and PQ with documentation review (VMP, URS, SOPs).
• Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11, GAMP 5, and Data Integrity.
• Work hands-on with ERP and laboratory systems; assess compliance and performance.
• Perform supplier audits and risk-based compliance checks.
• Represent Rephine on-site across Spain, Europe, and China, ensuring high-quality results.

Conocimientos

Fluent Spanish & English

Multitasking

Client-facing communication

Travel willingness

Educación

Bachelor's degree in Chemistry or Engineering

Herramientas

ERP systems

eDMS

eQMS

LIMS

SCADA

EBR systems

Pharmacovigilance systems

Descripción del empleo

Rephine Seville in Andalusia, Spain, is seeking a Computer System Validation Senior Consultant to lead ERP and critical computerized system validations in regulated environments. You will own IQ/OQ/PQ activities, review key documents, and drive compliance with EU GMP Annex 11, FDA 21 CFR Part 11, and GAMP 5 while collaborating with international teams.

Travel to client sites across Spain and Europe is expected, with on-site engagements in Barcelona and Seville, and occasional visits to China.