Job description
Mission
The Senior Quality Engineer is responsible for preventing deviations and improving compliance in a cGMP environment. The role focuses on analyzing quality deviations, identifying trends, and driving effective preventive and corrective actions across the organization.
You will work closely with local departments and topic leaders to ensure that processes, systems, and behaviors support the delivery of high‑quality, safe, and effective products.
Key Responsibilities:
Deviation & CAPA Management
Evaluate quality deviations to identify clusters, root causes, and trends
Act as an expert in deviation and CAPA management, ensuring robust investigations and actions
Identify effective preventive measures within the scope of the deviation program
Consolidate and maintain an action plan for the implementation of preventive measures
Change & Transformation
Collaborate with topic leaders and relevant departments to define and implement improvement actions
Guide departments in managing change, ensuring adoption of new or improved ways of working
Support Operational Excellence and transformation initiatives related to quality and compliance
Monitoring & Continuous Improvement
Monitor the progress of action plans and the effectiveness of implemented measures
Use data analysis and performance indicators to track trends and residual risks
Propose and drive continuous improvement initiatives to reduce deviations and non‑conformities
Compliance, Safety & cGMP
Operate in a cGMP environment, meeting all applicable quality and safety requirements and industry standards
Ensure compliance in areas such as production facilities, product safety, staff qualifications, procedures, and documentation
Implement policies related to employee well‑being, environmental and energy management, in line with training and instructions
Ensure proper use of work equipment and personal protective equipment (PPE)
Report incidents and non‑conformities and support the identification of risks and preventive measures
Act in line with the company’s culture, values, and standards
Profile Requirements
Experience & Background
7–10 years of work experience in a GMP environment (preferably in QA, QC, or Manufacturing)
Proven expertise in deviation/CAPA management
Experience in Operational Excellence and Transformation Management
Experience in project management (leading or coordinating improvement projects)
Dutch fluency is mandatory
Skills & Competencies
Strong analytical mindset
Excellent data analysis skills and ability to identify trends and patterns
Strong communication skills, able to influence and align multiple stakeholders
Proven team player, collaborative and supportive
Structured, organized, and result‑oriented
Soft Skills
Proactive and solution‑oriented
High sense of responsibility and ownership
Ability to work in a cross‑functional, international, and regulated environment
Comfortable challenging the status quo and driving change
Why joining us?
Rapid growth: Amaris has doubled its workforce in Belgium in two years, providing numerous growth opportunities for employees.
Prestigious projects: Candidates will work with renowned clients in the pharmaceutical, biotechnology, and European institutions sectors on impactful missions.
International environment: An agile and dynamic structure promotes intrapreneurship and meritocracy, with international exposure at the heart of Europe.
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 is an independent technology consulting 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 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!