QA MES PAS-X (F/H/X)

MANTU GROUP SA; Belgique; Hybrid; EUR 70,000 - 90,000; 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 Project Engineer MES to support compliant electronic master batch records for CAR-T manufacturing in Ghent and QA activities in Beerse. You will collaborate with MES experts, QA Operations, Manufacturing, IT and project teams to ensure GMP compliance and data integrity from planning through delivery.

Ideal candidates hold a relevant degree and 4–6 years of experience in the pharmaceutical sector, with hands-on work in MBR verification and MES systems.

Qualifications

• Bachelor’s or Master’s degree in bio-engineering, pharmacy, life sciences or related field.
• Experience with QA activities in GMP-regulated environments and pharmaceutical manufacturing.

Responsibilities

• Provide QA oversight for electronic master batch record verification activities.
• Review MBR checklists, Design Documentation Specifications, testing strategies, and test protocols.
• Review executed verification protocols and supporting evidence.
• Document comments and ensure actions are closed properly.
• Review traceability matrices, PQ documentation, project quality plans and go-live documentation.
• Support QA and data-integrity reviews of PAS-X master data and MES elements.
• Confirm project deliverables meet GMP and internal procedures.
• Identify and follow up on risks, deviations, test observations, and corrective actions.
• Support preparation and review of quality and validation documentation.
• Keep stakeholders informed with updates and escalation.
• Maintain inspection-ready documentation.
• Contribute to continuous improvement within the QA MES team.
• Work with international colleagues in English and Dutch.

Skills

QA oversight

cGMP knowledge

MBR verification

MES systems

PAS-X / Opstracker

English & Dutch

Education

Bachelor’s or Master’s degree in bioscience or related field

Tools

PAS-X

Opstracker

Job description

As a QA Project Engineer MES, you’ll support the delivery of compliant electronic master batch records for CAR-T manufacturing sites in Ghent and cryopreservation and Quality Control activities in Beerse.

You’ll work within the QA MES team and collaborate with MES technical experts, QA Operations, Manufacturing, IT, and project teams. Your role will focus on reviewing verification documentation, ensuring GMP and data-integrity requirements are met, and keeping QA deliverables on track from planning through completion.

Your missions

• Provide QA oversight for electronic master batch record verification activities, in line with approved procedures, timelines, and priorities.
• Review MBR checklists, Design Documentation Specifications, testing strategies, and test protocols.
• Review executed verification protocols and supporting evidence.
• Document comments, follow up on their resolution, and ensure that actions are closed properly.
• Review traceability matrices, Performance Qualification documentation, project quality plans, summary reports, and go-live documentation.
• Support QA and data-integrity reviews of PAS-X master data, electronic batch records, and other MES elements.
• Confirm that project deliverables meet GMP, data-integrity, and internal procedural requirements.
• Identify and follow up on risks, deviations, test observations, and corrective actions.
• Support the preparation and review of quality and validation documentation.
• Keep project stakeholders informed through clear updates and timely escalation.
• Maintain complete, accurate, and inspection-ready documentation.
• Contribute to continuous improvement within the QA MES team.
• Work closely with international colleagues and stakeholders in English and Dutch.

Your profile

• Bachelor’s or master’s degree in bio-engineering, pharmacy, life sciences, or another relevant technical or scientific field.
• 4 to 6 years of professional experience, including at least 3 years in the pharmaceutical industry or another GMP-regulated environment.
• Practical experience with QA activities in pharmaceutical manufacturing.
• Good knowledge of cGMP requirements and relevant pharmaceutical regulations.
• Experience with master batch records in a GMP production environment.
• Experience reviewing MBR verification, qualification, or validation documentation.
• Experience with MES production systems, ideally PAS-X or Opstracker.
• Fluent in English and Dutch.

What we offer

Joining Amaris means working in an environment where your performance supports your career progression.

Projects with substance
Our projects last 18 months on average and involve major accounts such as Orange, Sanofi, SNCF, and CMA-CGM. You’ll work on assignments where your experience has a direct impact on project delivery and product quality.

Support from your manager and HR
Each manager supports up to 18 consultants. You’ll have regular project check-ins and a direct exchange with HR every month through Express Yourself. Our teams have an average tenure of 3.3 years.

Career progression
70% of our managers started in entry-level positions. Career development is based on skills, performance, and the opportunities you take. Functional mobility across 4 areas of expertise and international mobility across 60+ countries are actively encouraged.

Learning and technology
You’ll have access to 250+ training modules, fully funded Microsoft certifications, and 291 AI agents developed in-house. We support continuous learning throughout your career.

Social and environmental commitments
Our commitments include an SBTi carbon reduction roadmap, a target of 34.3% women in management by 2029, and social engagement through We Care Together.

• Health insurance
• Remote work
• Meal vouchers
• A time savings account
• Referral bonus

We’ll discuss the full benefits package during the recruitment process.

Amaris Consulting is proud to be an equal-opportunity workplace. We’re committed to building a diverse and inclusive working environment. We welcome applications from all qualified candidates, regardless of gender, sexual orientation, race, ethnicity, beliefs, age, marital status, disability, or any other characteristic.

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.