16 oct
|
Rephine
|
Madrid
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 general 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, but as a validator who has owned the full lifecycle
Proven ability to author complete validation documentation autonomously (VMP, URS, IQ/OQ/PQ, risk assessments, validation reports) from scratch
Strong practical knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity principles
Experience in a consulting or multi-client environment — you know what it means to manage competing priorities across different projects
Genuine passion for consulting — you thrive on variety, pace and client interaction
Willingness to travel to client sites when required — this is non-negotiable
Fluency in English — written and spoken. Spanish is a significant plus
Valid driver's license
Authorisation to work in the EU
Why This Role Could Excite You:
Work across multiple pharma clients and ERP environments — building expertise faster than you would in any single company
Be part of a team led by a CSV Director with 25 years of experience — real mentorship from industry experts
Grow towards L1 Tech and Line Director with a clear, structured career path
Join a company where people stay — 10, 20 and even 30 years — because the environment is genuinely worth it
Why Choose Rephine?
Competitive salary aligned to your experience, with annual bonus linked to company objectives
Remote for EU-based profiles — occasional travel to client sites and Barcelona office when required
Birthday gift card and Summer Relax flexibility
2 team building events per year
International project exposure across Spain, UK and Europe
Structured onboarding with dedicated internal trainers
📌 CSV Consultant — ERP Validation | GxP Pharma (Madrid)
🏢 Rephine
📍 Madrid