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.