QA Qualification/Validation ( F/M/X)

Amaris Consulting | Part of Mantu; Geel; Sur place; EUR 60 000 - 90 000; Plein temps

Avantages offerts par ce poste

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Résumé du poste

Amaris Consulting, part of Mantu, is seeking a QA/Validation professional to support qualification activities across the lifecycle of pharmaceutical systems. You will review documents, ensure cGMP compliance, and collaborate with manufacturing, IT, and automation teams to implement robust validation strategies.

You will address deviations, communicate status to the QA team, and help translate technical requirements into accessible content for all levels of the organization.

Qualifications

• Experience in the chemical/pharma industry with qualification/validation focus.
• Knowledge of cGMP regulations and guidelines is required.
• Experience with manufacturing, laboratory, building, utility, IT, and automation systems in pharma/chemical industry.
• Familiarity with problem report and change request systems (Trackwise, Comet).
• Experience with document management systems (TruVault) and test tools (Kneat).

Responsabilités

• Support QA Engineering to ensure regulatory and procedural requirements are fulfilled.
• Review and approve qualification/validation docs and quality records to maintain compliance.
• Collaborate with engineering teams for new or upgraded systems and processes.
• Provide advice/support for qualification/validation activities ensuring cGMP.
• Address and follow up on deviations during qualification/validation activities.
• Communicate status regarding quality, compliance, and planning to QA team.

Connaissances

Pharma industry experience

cGMP knowledge

Cross-functional collaboration

Communication skills

English and Dutch fluent

Documentation reading/writing

Outils

Trackwise

Comet

TruVault

Kneat

Description du poste

Job Description

Join our team and start a new adventure in an international and dynamic environment, where you will be able to fulfil your career expectations in a fast-growing organization.

Your missions

• Support the QA Engineering department to ensure all qualification/validation regulatory and procedural requirements are fulfilled throughout the system lifecycle.
• Review and approve qualification/validation documents and quality records (SOPs, user requirements, impact/risk analyses, test plans, test scripts, change controls, CAPAs, etc.) to maintain compliance with regulations, guidelines, and company policies.
• Participate in engineering teams and collaborate with other groups for the introduction of new or upgraded systems and processes.
• Provide advice and support for the preparation of qualification/validation activities, ensuring cGMP aspects are respected.
• Address and follow up on deviations occurring during qualification/validation activities.
• Communicate status regarding quality, compliance, and planning to the QA qualification/validation team members.

Your profile

• Experience in the chemical and/or pharmaceutical industry with a focus on qualification/validation.
• Knowledge of cGMP regulations and guidelines.
• Experience with manufacturing, laboratory, building, utility, IT, and automation systems used in the pharmaceutical or chemical industry.
• Familiarity with problem report and change request systems (e.g., Trackwise, Comet).
• Experience with document management systems (e.g., TruVault).
• Experience with test tools (e.g., Kneat).
• Capacity to translate technical information into accessible content for all levels of the organization.
• Ability to correctly estimate urgency, criticality, and impact of decisions related to the function.
• Ability to multi-task and manage a variety of projects simultaneously.
• Ability to work independently and within cross-functional teams.
• You demonstrate strong communication skills.
• English and Dutch fluent.

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 discuss the full benefits breakdown during our meetings.

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.

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

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!