QA Specialist - Commissionning & Qualification (F/M/X)

AMARIS GROUP SA; Beerse; On-site; EUR 70,000 - 90,000; Full time

Benefits offered by this job

Health insurance

Remote work options

Meal vouchers

Time savings account

Referral bonus

Job summary

Amaris Group SA is seeking a Life Sciences Consultant to support qualification and compliance activities within a dynamic, international environment. You will participate in system lifecycle projects, review URS, risk assessments, validation protocols, and qualification reports to ensure regulatory alignment and company standards.

English is required and Dutch is preferred. Join a global team focused on quality, continuous improvement, and cross-functional collaboration across major life science

Qualifications

• Experience in a regulated environment, ideally within the pharmaceutical or life sciences sector.
• 3–7 years of qualification activities and/or QA experience.
• Strong knowledge of international regulations and industry standards (GMP, GAMP, FDA, EMA).
• Experience with deviation management and CAPA processes.
• Proficiency in reviewing and approving technical documentation (URS, protocols, reports).
• Academic background: scientific or engineering degree.

Responsibilities

• Participate in change projects throughout the system lifecycle.
• Review and approve qualification deliverables (URS, risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, reports).
• Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems.
• Assess and address deviations with potential impact on quality/compliance through CAPA actions.
• Maintain current understanding of applicable international regulations and industry practices.
• Support regulatory inspections, customer audits, and internal compliance assessments.
• Collaborate with cross-functional stakeholders to meet timelines and objectives.

Skills

QA in life sciences

GMP/GAMP knowledge

Regulatory compliance

Documentation review

Education

Scientific or engineering degree

Job description

Permanent Job

Join our team as a Life Sciences Consultant and play a key role in supporting qualification and compliance activities for our client’s project within a dynamic and international environment, where you will be able to fulfil your career expectations in a fast-growing organization.

Your missions

• Participate in change projects throughout the entire system lifecycle.
• Review and approve qualification deliverables including User Requirements Specifications (URS), risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, and qualification reports to ensure compliance with applicable regulations, industry guidelines, and company standards.
• Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems.
• Ensure that deviations related to systems (qualification, maintenance, calibration, and/or use) with potential impact on quality and/or compliance are appropriately assessed, thoroughly investigated, and effectively addressed through adequate corrective and preventive actions.
• Maintain a current understanding of applicable international regulations, guidelines, and industry practices related to system qualification and apply this knowledge to continuously improve qualification processes.
• Support regulatory inspections, customer audits, and internal compliance assessments by ensuring audit readiness and providing subject matter expertise on qualification-related topics.
• Collaborate closely with cross-functional stakeholders involved in qualification and lifecycle management activities to ensure project timelines are achieved and organizational objectives are met.

Your profile

• Experience in a regulated environment, ideally within the pharmaceutical or life sciences sector.
• Demonstrated 3 to 7 years of expertise in qualification activities and/or previous experience in a QA role.
• Strong knowledge of international regulations and industry standards (e.g., GMP, GAMP, FDA, EMA).
• Experience with deviation management and CAPA processes.
• Proficiency in reviewing and approving technical documentation (URS, protocols, reports).
• Academic background: scientific or engineering degree.
• English mandatory and Dutch preferred.
• You demonstrate a strong quality and compliance mindset.
• You are able to challenge constructively while maintaining a positive and productive relationship with stakeholders.

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?

Job description

Join our team as a Life Sciences Consultant and play a key role in supporting qualification and compliance activities for our client’s project within a dynamic and international environment, where you will be able to fulfil your career expectations in a fast-growing organization.

Your missions

• Participate in change projects throughout the entire system lifecycle.
• Review and approve qualification deliverables including User Requirements Specifications (URS), risk assessments, DQ/IQ/OQ/PQ protocols, test scripts, and qualification reports to ensure compliance with applicable regulations, industry guidelines, and company standards.
• Review and approve procedures related to qualification, calibration, maintenance, and lifecycle management of systems.
• Ensure that deviations related to systems (qualification, maintenance, calibration, and/or use) with potential impact on quality and/or compliance are appropriately assessed, thoroughly investigated, and effectively addressed through adequate corrective and preventive actions.
• Maintain a current understanding of applicable international regulations, guidelines, and industry practices related to system qualification and apply this knowledge to continuously improve qualification processes.
• Support regulatory inspections, customer audits, and internal compliance assessments by ensuring audit readiness and providing subject matter expertise on qualification-related topics.
• Collaborate closely with cross-functional stakeholders involved in qualification and lifecycle management activities to ensure project timelines are achieved and organizational objectives are met.

Your profile

• Experience in a regulated environment, ideally within the pharmaceutical or life sciences sector.
• Demonstrated 3 to 7 years of expertise in qualification activities and/or previous experience in a QA role.
• Strong knowledge of international regulations and industry standards (e.g., GMP, GAMP, FDA, EMA).
• Experience with deviation management and CAPA processes.
• Proficiency in reviewing and approving technical documentation (URS, protocols, reports).
• Academic background: scientific or engineering degree.
• English mandatory and Dutch preferred.
• You demonstrate a strong quality and compliance mindset.
• You demonstrate strong communication skills.
• You are able to challenge constructively while maintaining a positive and productive relationship with stakeholders.

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.

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!