Join Rephine: 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, India and China, we support the Pharmaceutical, Biotech and Medical Device supply chains globally. Who We're Looking For: Are you an experienced ERP validation professional with a strong pharmaceutical QA background? Do you have a proven track record validating ERP systems in GxP-regulated environments and want to take that expertise into a dynamic integral consultancy? If you are passionate about consulting, comfortable working across multiple projects and ready to travel when needed, we want you as our next ERP Validation Consultant | Pharmaceutical & GxP (L2). Your Role: As an L2 ERP Validation Consultant, you will lead the validation of ERP systems and their integrations in pharmaceutical environments, working autonomously across multiple client projects. You will be the technical reference for ERP validation,



managing documentation end-to-end and building trusted relationships with your clients. Key Responsibilities: * Lead end-to-end validation of ERP systems (SAP and others) and their integrations with GxP systems in pharmaceutical environments * Own and author all validation documentation: VMPs, URS, IQ/OQ/PQ protocols, risk assessments, traceability matrices and validation reports * Apply GAMP 5 risk-based approaches for system categorisation and validation scope definition * Ensure compliance with EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity (ALCOA+) guidelines * Manage multiple concurrent client projects with autonomy and deliver on time * Act as client-facing representative for Rephine in meetings, on-site visits and stakeholder sessions * Support audits and inspections as the ERP validation subject matter expert What We're Looking For: * Minimum 5 years of hands-on ERP validation experience in GxP-regulated pharmaceutical environments — not just as a user,

📌 CSV Consultant — ERP Validation | GxP Pharma (Bilbao)
🏢 Rephine
📍 Bilbao