QA-CSV Specialist

Amaris Consulting | Part of Mantu; Beerse; On-site; EUR 60,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting, part of Mantu, is seeking a QA-CSV Specialist to provide independent quality oversight and practical CSV support for execution systems used in GxP manufacturing. You will collaborate with Execution Systems, Automation, Engineering, IT, system owners, and business representatives to keep validation activities risk-based, traceable, and inspection-ready.

In this role you will review validation deliverables, assess changes, incidents, deviations, and CAPAs for impact on product

Qualifications

• Experience with lifecycle documentation, testing, change control, and deviation management.
• Experience with GxP-regulated computerized systems.
• Knowledge of CSV, SDLC, EU GMP Annex 11, US FDA 21 CFR Part 11, GAMP 5, and data integrity expectations.

Responsibilities

• 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.

Skills

CSV validation

Quality assurance

GxP knowledge

Risk-based validation

Data integrity

Lifecycle documentation

English and Dutch fluent

Tools

SIMATIC Logon

Active Directory

Patch management

Backup and restore

Job description

Job Description

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.

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, part of Mantu is an independent technology consulting firm providing guidance and solutions to businesses. With more than 1,000 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 of 7,600 people spread across 5 continents and more than 60 countries. 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.

At Amaris, we strive to provide our candidates with the best possible recruitment experience. We like to get to know our candidates, challenge them, and be able to give them proper feedback as quickly as possible. Here’s what our recruitment process looks like:

Brief Call

Our process typically begins with a brief virtual/phone conversation to get to know you! The objective? Learn about you, understand your motivations, and make sure we have the right job for you!

Interviews

(the average number of interviews is 3 - the number may vary depending on the level of seniority required for the position). During the interviews, you will meet people from our team: your line manager of course, but also other people related to your future role. We will talk in depth about you, your experience, and skills, but also about the position and what will be expected of you. Of course, you will also get to know Amaris: our culture, our roots, our teams, and your career opportunities!

Case study

Depending on the position, we may ask you to take a test. This could be a role play, a technical assessment, a problem-solving scenario, etc.

As you know, every person is different and so is every role in a company. That is why we have to adapt accordingly, and the process may differ slightly at times. However, please know that we always put ourselves in the candidate's shoes to ensure they have the best possible experience.

We look forward to meeting you!