QA-CSV Specialist

AMARIS GROUP SA; Beerse; Hybride; EUR 60 000 - 100 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting is seeking a QA-CSV Specialist to provide independent quality oversight for execution systems within a GxP environment. You will collaborate with Execution Systems, Automation, Engineering, IT, and business representatives to ensure validation activities remain risk-based, traceable, and inspection-ready.

You will review and approve validation deliverables such as impact assessments, validation plans, requirements, risk assessments, specifications, test documentation,

Qualifications

• Must have experience in CSV, validation, QA, automation, or computerized systems within a GxP-regulated environment (typically 4–7 years).
• 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.
• Solid knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity expectations including PIC/S guidance.

Responsabilités

• 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.
• Communicate quality risks clearly and elevate material compliance concerns when required.

Connaissances

CSV validation

Quality assurance

GxP regulatory

Lifecycle documentation

Risk-based validation

Outils

Active Directory

SIMATIC Logon

Group policies

Backup & restore

File-transfer services

Description du poste

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 elevate material compliance concerns when required

Systems in scope

• PLC 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)
• 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
• English and Dutch fluent.

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

Joining 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.

In practical terms, here’s what this means for you on a daily basis:

• Projects 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.
• Real 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.
• A 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.
• Innovation, in practice 291 AI agents built in-house, 250+ training modules, Microsoft certifications fully funded. At Mantu, AI stands for Artificial Intelligence — and Augmented Impact.
• CSR with real targets SBTi carbon reduction roadmap, 32% women in management (target: 34.3% by 2029), social engagement through We Care Together.
• Health insurance, remote work, meal vouchers, time savings account, referral bonus… We’ll talk about our full benefits package during our interviews.

Mantu 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.

Who are we?

Amaris Consulting isan independent technologyconsulting firm providing guidance and solutions to businesses. With more than 1000 clients across the globe, we have been rolling out solutions in major projects for over a decade – this is made possible by an international team of7,600 people spread across 5 continents and more than 60countries. Our solutions focus on four different Business Lines: Information System & Digital, Telecom, Life Sciences and Engineering. We’re focused on building and nurturing a top talent community where all our team members can achieve their full potential. Amaris is your steppingstone to cross rivers of change, meet challenges and achieve all your projects with success.