Csv Consultant - Erp Validation | Gxp Pharma
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Job description
| Join Rephine: Leading Life Sciences Quality WorldwideAt 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 global 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 environmentsOwn and author all validation documentation: VMPs, URS, IQ/OQ/PQ protocols, risk assessments, traceability matrices and validation reportsApply GAMP 5 risk-based approaches for system categorisation and validation scope definitionEnsure compliance with EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity (ALCOA+) guidelinesManage multiple concurrent client projects with autonomy and deliver on timeAct as client-facing representative for Rephine in meetings, on-site visits and stakeholder sessionsSupport audits and inspections as the ERP validation subject matter expertWhat 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 lifecycleProven ability to author complete validation documentation autonomously (VMP, URS, IQ/OQ/PQ, risk assessments, validation reports) from scratchStrong practical knowledge of GAMP 5, EU GMP Annex 11, FDA 21 CFR Part 11 and Data Integrity principlesExperience in a consulting or multi-client environment - you know what it means to manage competing priorities across different projectsGenuine passion for consulting - you thrive on variety, pace and client interactionWillingness to travel to client sites when required - this is non-negotiableFluency in English - written and spoken. Spanish is a significant plusValid driver’s licenseAuthorisation to work in the EUWhy This Role Could Excite You:Work across multiple pharma clients and ERP environments - building expertise faster than you would in any single companyBe part of a team led by a CSV Director with 25 years of experience - real mentorship from industry expertsGrow towards L1 Tech and Line Director with a clear, structured career pathJoin a company where people stay - 10, 20 and even 30 years - because the environment is genuinely worth itWhy Choose Rephine?Competitive salary aligned to your experience, with annual bonus linked to company objectivesRemote for EU-based profiles - occasional travel to client sites and Barcelona office when requiredBirthday gift card and Summer Relax flexibility2 team building events per yearInternational project exposure across Spain, UK and EuropeStructured onboarding with dedicated internal trainers#J-*****-Ljbffr |
Requirements
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
Benefits & conditions
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 #J-*****-Ljbffr
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