Computer System Validation

il y a 3 jours


Antwerp, Belgique Q795 Temps plein

Computer System Validation (CSV) Lead & Specialists QbD 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 integrity Join a strong expert community with knowledge sharing and mentoring Grow in either a leadership or technical expert career path Competitive and transparent package aligned with your experience Your role CSV Lead Lead 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 guidance Represent QbD in client meetings and audits CSV Specialist Execute validation for GxP systems (ERP, LIMS, MES, QMS, ...) Create/review documentation (URS, RA, test plans, IQ/OQ/PQ) Perform impact & gap assessments, vendor assessments Support audits, inspections, change control and deviations Ensure compliance with Annex 11, 21 CFR Part 11, GAMP5 What you bring CSV Lead 8–10+ years CSV/CSA experience in GxP environments Strong validation & project leadership skills Fluent in Dutch & English CSV Specialist 3–8 years CSV experience in Pharma/Biotech Knowledge of GAMP5, Annex 11, 21 CFR Part 11 Fluent in Dutch & English (French is a plus) Bonus: MES validation, cloud/SaaS validation, ALCOA+, Agile/DevOps, EBR/serialization.



  • Antwerp, Belgique 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...


  • Antwerp, Belgique 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...


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