QA-CSV Specialist

h3Job Description /h3 pYou will join our team as a QA-CSV Specialist, providing independent quality oversight and practical CSV support for execution systems used in GxP manufacturing. In this role, you will collaborate with Execution Systems, Automation, Engineering, IT, system owners, and business representatives to ensure that validation activities and lifecycle decisions remain risk-based, traceable, and inspection-ready. /p pYou will join our team as a QA-CSV Specialist, providing independent quality oversight and practical CSV support for execution systems used in GxP manufacturing. In this role, you will collaborate with Execution Systems, Automation, Engineering, IT, system owners, and business representatives to ensure that validation activities and lifecycle decisions remain risk-based, traceable, and inspection-ready. /p h3Your missions /h3 ul liProvide QA-CSV support throughout the system lifecycle, including projects, changes, operation, periodic review, and retirement /li liReview and approve validation deliverables such as impact and compliance assessments, validation plans, requirements, risk assessments, specifications, test documentation, traceability, and summary reports /li liAssess changes, incidents, deviations, defects, and CAPAs for impact on product quality, patient safety, data integrity, and the validated state /li liApply and promote a pragmatic, risk-based validation approach focused on critical functions, data, interfaces, and controls /li liAssess data integrity controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention, and data transfer /li liSupport data-flow mapping and clarify system boundaries, interfaces, critical records, metadata, and control ownership /li liSupport periodic reviews, inspection readiness, and audit or inspection questions for assigned systems /li liCommunicate quality risks clearly, challenge constructively, and elevate material compliance concerns when required /li /ul h3Systems in scope /h3 ul liPLC and SCADA-based automation and visualization systems /li liParticle and environmental monitoring systems /li liAutomation Network Shared Services, including Active Directory, access and policy management, backup and restore, patching, antivirus, and infrastructure monitoring /li liData-copy and file-transfer services, SIMATIC Logon, and related servers, workstations, interfaces, and network dependencies /li /ul h3Your profile /h3 ul liExperience in CSV, validation, quality assurance, automation, or computerized systems within a GxP-regulated environment (typically 4-7 years) /li liPractical experience with lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state /li liExperience with manufacturing, monitoring, automation, or infrastructure-related computerized systems /li liGood working knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and recognized data integrity expectations, including PIC/S guidance /li liUnderstanding of risk-based validation, electronic records and signatures, access controls, audit trails, backup and restore, interfaces, and supplier documentation /li liAbility to understand technical system architecture and translate it into clear validation and quality decisions /li liEffective communication, collaboration, and organization skills, with the confidence to challenge while maintaining a solution-oriented approach /li liEnglish and Dutch fluent. /li /ul h3Preferred Experience /h3 ul liPLC/SCADA, industrial automation networks, shop-floor systems, or particle monitoring solutions /li liActive Directory, group policies, SIMATIC Logon, patching, antivirus, backup and restore, monitoring, or file-transfer services /li liData-flow mapping, data integrity risk assessments, periodic reviews, or inspection support /li /ul h3What

we offer
/h3 pJoining Amaris isn’t about joining a company where you simply wait patiently for a vacancy to arise. It’s about becoming part of an environment where your performance directly drives your career progression. /p pIn practical terms, here’s what this means for you on a daily basis: /p pProjects worth your time 18+ months on average, with major accounts (Orange, Sanofi, SNCF, CMA-CGM...) and the support of our internal Centers of Excellence. You get the depth, not just the breadth. /p pReal management support 1 manager for up to 18 consultants, structured project check-ins, and a direct line to HR every month through Express Yourself. Our teams average 3.3 years of tenure
- proof that we build something that lasts. /p pA career that actually moves 70% of our managers started at entry level. Average age: 36. Here, trust comes before experience and merit drives progression
- not seniority. Functional (4 areas of expertise) and geographic (60+ countries) mobility are actively encouraged. /p pInnovation, in practice 291 AI agents built in-house, 250+ training m