Computer System Validation

il y a 14 heures


Belgium Q795 Temps plein

Computer System Validation (CSV) Lead & SpecialistsQbD Group supports companies in Pharma, ATMP and Medical Devices/IVD with expert knowledge and tailored software solutions. We are looking for CSV Leads and CSV Specialists to support GxP computerized systems validation projects. What's in it for you?Work on impactful CSV/CSA projects ensuring patient safety & data integrityJoin a strong expert community with knowledge sharing and mentoringGrow in either a leadership or technical expert career pathCompetitive and transparent package aligned with your experience Your roleCSV LeadLead end-to-end CSV/CSA projects (planning → execution → closure)Act as SPOC for validation teams and stakeholders (QA/IT/Business)Apply risk-based validation (GAMP5, CSA)Ensure quality deliverables, timelines and team guidanceRepresent QbD in client meetings and auditsCSV SpecialistExecute validation for GxP systems (ERP, LIMS, MES, QMS, ...)Create/review documentation (URS, RA, test plans, IQ/OQ/PQ)Perform impact & gap assessments, vendor assessmentsSupport audits, inspections, change control and deviationsEnsure compliance with Annex 11, 21 CFR Part 11, GAMP5 What you bringCSV Lead8–10+ years CSV/CSA experience in GxP environmentsStrong validation & project leadership skillsFluent in Dutch & EnglishCSV Specialist3–8 years CSV experience in Pharma/BiotechKnowledge of GAMP5, Annex 11, 21 CFR Part 11Fluent in Dutch & English (French is a plus) Bonus: MES validation, cloud/SaaS validation, ALCOA+, Agile/DevOps, EBR/serialization.



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