Computer System Validation Consultant (Pontevedra)

Overview

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, China, and India, we support the Pharmaceutical, Biotech, and Medical Device supply chains globally.

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, foc...