Computer System Validation
il y a 6 heures
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 experienceYour 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, GAMP5What 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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Computer System Validation
il y a 7 jours
Antwerp, Belgique Q795 Temps pleinComputer 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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Computer System Validation
il y a 7 jours
Antwerp, Belgique Q795 Temps pleinComputer 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...
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Computer System Validation
il y a 7 jours
Antwerp, Belgique Q795 Temps pleinComputer 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...
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Computer System Validation
il y a 4 jours
Antwerp, Belgique WhatJobs Temps pleinJob Title Location : Hybrid Type : Full-time 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 &...
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Consultant: CSV Validation Engineer
il y a 2 semaines
Antwerp, Belgique Avertim Temps pleinAbout Avertim Avertim is a uniquely positioned management consulting group that bridges the gap between strategy, technology, and operations. Founded in 2007 and headquartered on Brussels' iconic Avenue Louise, Avertim has grown into a European consultancy with over 350 consultants across Belgium, France, Germany, and the Netherlands. Our mission: to support...
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Consultant: CSV Validation Engineer
il y a 2 semaines
Antwerp, Belgique Avertim Temps pleinAbout Avertim Avertim is a uniquely positioned management consulting group that bridges the gap between strategy, technology, and operations. Founded in 2007 and headquartered on Brussels' iconic Avenue Louise, Avertim has grown into a European consultancy with over 350 consultants across Belgium, France, Germany, and the Netherlands. Our mission: to support...
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Validation Engineer
il y a 8 heures
Antwerp, Belgique Arcadis Temps pleinBen jij een gedreven Validation Engineer met ervaring in de validatie van softwarepakketten en geautomatiseerde systemen binnen de farmaceutische sector? Dan zijn wij op zoek naar jou! Je wordt verantwoordelijk voor het ontwikkelen, implementeren en uitvoeren van validatieactiviteiten voor cGMP-kritische computersystemen. Je werkt hands-on mee aan het...
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Cleaning Validation Engineer
il y a 7 heures
Antwerp, Belgique Arcadis Temps pleinAs a Cleaning Validation Engineer, you will support our client in ensuring their cleaning processes meet the highest GMP and regulatory standards.Key ResponsibilitiesPrepare and update cleaning validation documentation (protocols, reports, studies)Prioritize and coordinate cleaning validation projects related to process changesPrepare and support internal...
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Senior Ubuntu Embedded IoT System Engineer
il y a 5 jours
Antwerp, Belgique WhatJobs Temps pleinSenior Ubuntu Embedded IoT System Engineer Canonical is a leading provider of open source software and operating systems to the global enterprise and technology markets. Our platform, Ubuntu, is very widely used in breakthrough enterprise initiatives such as public cloud, data science, AI, engineering innovation, and IoT. Our customers include the world's...
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Validation & Qualification Consultant
il y a 2 jours
Antwerp, Belgique WhatJobs Temps pleinVerbeteren, daar draait het om bij Agidens. Daarom luidt ons motto dan ook 'progress never stops'. Onze consultants geven elke dag het beste van zichzelf om klanten te helpen bij het verbeteren van hun processen en procedures. Onze teams van experts streven voortdurend naar de volledige naleving van de geldende GMP-voorschriften in de farmaceutische en...
