QA Qualification/Validation Consultant

Mantu; Geel; On-site; EUR 55,000 - 85,000; Full time

Benefits offered by this job

Health insurance

Remote work

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Consulting is seeking a QA Qualification/Validation specialist to support regulatory compliance across the system lifecycle. You will review qualification documents, ensure cGMP adherence, and collaborate with engineering and other groups to implement new or upgraded systems.

You will communicate status on quality, compliance, and planning to the QA team, manage deviations, and help prepare qualification activities in line with regulatory guidelines.

Qualifications

• Experience in chemical/pharma industry with qualification/validation.
• Knowledge of cGMP regulations and guidelines.
• Experience with manufacturing, laboratory, building, utility, IT, and automation systems in pharma/chemical industry.

Responsibilities

• Support QA Engineering to ensure qualification/validation requirements are fulfilled throughout the system lifecycle.
• Review and approve qualification/validation documents and quality records to maintain compliance.
• Participate in engineering teams and collaborate on new or upgraded systems and processes.
• Advise on qualification activities ensuring cGMP aspects are respected.
• Address deviations during qualification/validation activities.
• Communicate status regarding quality, compliance, and planning to the QA team.

Skills

GMP awareness

Regulatory compliance

Project management

Cross-functional teamwork

Analytical thinking

Tools

Trackwise

Comet

TruVault

Kneat

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.
• English and Dutch fluent. (Mandatory)
• 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.

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.