QA CSV Specialist

You 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. Your missions
• Provide QA-CSV support throughout the system lifecycle, including projects, changes, operation, periodic review, and retirement
• Review and approve validation deliverables such as impact and compliance assessments, validation plans, requirements, risk assessments, specifications, test documentation, traceability, and summary reports
• Assess changes, incidents, deviations, defects, and CAPAs for impact on product quality, patient safety, data integrity, and the validated state
• Apply and promote a pragmatic, risk-based validation approach focused on critical functions, data, interfaces, and controls
• Assess data integrity controls for access management, audit trails, electronic records and signatures, time synchronization, backup, restore, retention, and data transfer
• Support data-flow mapping and clarify system boundaries, interfaces, critical records, metadata, and control ownership
• Support periodic reviews, inspection readiness, and audit or inspection questions for assigned systems
• Communicate quality risks clearly, challenge constructively, and escalate material compliance concerns when required
• Systems in scopePLC and SCADA-based automation and visualization systems
• Particle and environmental monitoring systems
• Automation Network Shared Services, including Active Directory, access and policy management, backup and restore, patching, antivirus, and infrastructure monitoring
• Data-copy and file-transfer services, SIMATIC Logon, and related servers, workstations, interfaces, and network dependencies

Your profile
• Experience in CSV, validation, quality assurance, automation, or computerized systems within a GxP-regulated environment (typically 4-7 years)
• English and Dutch fluent.
• Practical experience with lifecycle documentation, testing, change control, deviation management, and maintenance of the validated state
• Experience with manufacturing, monitoring, automation, or infrastructure-related computerized systems
• Good 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
• Understanding of risk-based validation, electronic records and signatures, access controls, audit trails, backup and restore, interfaces, and supplier documentation
• Ability to understand technical system architecture and translate it into clear validation and quality decisions
• Effective communication, collaboration, and organization skills, with the confidence to challenge while maintaining a solution-oriented approach Preferred experience
• PLC/SCADA, industrial automation networks, shop-floor systems, or particle monitoring solutions
• Active Directory, group policies, SIMATIC Logon, patching, antivirus, backup and restore, monitoring, or file-transfer services
• Data-flow mapping, data integrity risk assessments, periodic reviews, or inspection support

What we offer
• An international community bringing together 110+ different nationalities
• An environment where trust has a central place: 70% of our key leaders started their careers at the first level of responsibilities
• A robust training system with our internal Academy and 250+ available modules
• A vibrant workplace that frequently gathers for internal events (afterworks, team buildings, etc.)
• At Mantu, sustainability is part of everything we do. You’ll have the opportunity to turn your ideas into action and make a tangible impact. Every day, our teams bring our ESG commitments to life, from reducing our footprint to driving positive change within our communities. Through our WeCare Together program, you’ll be empowered to design and lead projects that create real social or environmental impact, with the company’s full support.[doc1][doc2][doc3] Amaris Consulting is proud to be an equal-opportunity workplace. We are committed to promoting diversity within the workforce and creating an inclusive working environment. For this purpose, we welcome applications from all qualified candidates regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or other characteristics.