Quality Engineer - Life Sciences

Avertim Netherlands; Leiden; On-site; EUR 52,000 - 78,000; Full time

Job summary

Avertim Netherlands is seeking a Quality Engineer to help expand our Life Sciences consulting activities. You will ensure GMP compliance by managing NCs, driving CAPAs, and leading deviations investigations in a cross-functional setting.

Located in Amsterdam-Zuid, you will work with teams across regulatory and production functions to enhance quality processes and sustain industry standards. Fluency in English is required; Dutch is a plus.

Qualifications

• Master’s degree required in Engineering, Pharmacy, Life Sciences or related field.
• Minimum of 3 years of experience in Pharmaceuticals, Biotech or Medical Devices.
• Hands-on experience with NC management, CAPA implementation, change controls, and deviation investigations.

Responsibilities

• Lead the investigation, documentation, and resolution of NCs, ensuring timely and effective CAPA implementation, and manage change controls.
• Perform root cause analyses and risk assessments to prevent recurrence of deviations.
• Ensure compliance with GMP, FDA, EMA, and other regulatory requirements in all quality-related activities.
• Collaborate with production, quality control, and regulatory teams to drive improvements in GMP processes.
• Conduct internal audits and support external regulatory inspections.
• Maintain and improve SOPs, batch records, and other GMP documentation.
• Provide GMP training and guidance to operational teams to enhance compliance awareness.

Skills

NC management

CAPA implementation

Deviation investigations

GMP compliance

Root cause analysis

Quality systems

Project management

Education

Master’s degree in Engineering, Pharmacy, Life Sciences

Job description

Avertim Netherlands is currently looking for Quality Engineers able to assist in the continuous expansion of Avertim’s consulting activities in Life Sciences. Located in Amsterdam-Zuid, Avertim Netherlands is a trusted partner by the largest players in the Life Sciences sector.

As a Quality Engineer, you will play a key role in ensuring GMP compliance by managing and resolving Non-Conformities (NCs) and driving continuous improvement in quality processes. You will collaborate closely with cross-functional teams to investigate deviations, implement corrective and preventive actions (CAPAs), and uphold regulatory standards.

Key responsibilities:

• Lead the investigation, documentation, and resolution of NCs, ensuring timely and effective CAPA implementation, and manage change controls.
• Perform root cause analyses and risk assessments to prevent recurrence of deviations.
• Ensure compliance with GMP, FDA, EMA, and other regulatory requirements in all quality-related activities.
• Collaborate with production, quality control, and regulatory teams to drive improvements in GMP processes.
• Conduct internal audits and support external regulatory inspections.
• Maintain and improve SOPs, batch records, and other GMP documentation.
• Provide GMP training and guidance to operational teams to enhance compliance awareness.

Your background:

• A Master’s Degree in Engineering, Pharmacy, Life Sciences or related field
• Minimum of 3 years of experience in Pharmaceuticals, Biotech or Medical Devices.
• Hands-on experience with NC management, CAPA implementation, change controls, and deviation investigations.
• Experience in cell & gene therapy is a plus.
• Planning & organization – Planning & organization plans and organizes own work(load) in an effective way by setting priorities and meeting deadlines;
• Communicating & influencing – Communicates with clarity, speaks and writes clearly and to the point; active listener;
• Proficiency in Lean and Six Sigma methodologies or Project Management
• Fluent in English, Dutch is a plus
• Dutch working permit, sponsorship not possible

As an Avertimer, you will get the opportunity to:

• Immerse yourself into a young, vibrant, fast-growing team at our modern office, located in the Amsterdam business district, de Zuidas
• Enjoy our events, like team activities and afterworks.
• Develop yourself in a place where individuals and ideas matter, in line with our company values:

Be yourself

Trust, ownership and respect

Listen and act

• With offices in Brussels, Paris, Frankfurt and Amsterdam you will benefit from our international community. On top of that, we also support the opportunity to perform projects at multiple locations.
• Access various learning and development opportunities and an interesting career track. You will also receive a competitive compensation package in line with your experience.

About Avertim:

Avertim is a uniquely positioned Management Consulting Group that bridges the gap between Strategy and Operations. Our mission is to translate the strategy of our clients into actionable projects and enable the alignment between Business, Technology and Management. Founded in 2007, and headquartered on Brussels’ famous Louise Avenue, Avertim has grown into a European consultancy group with more than 300 consultants and offices in Belgium, France, Germany, and the Netherlands.

Looking for a challenging and exciting new step in your career at a recognised international consultancy firm that works with the top players in the Life Sciences sector?

At Avertim, we value talent and mindset. No difference will be made during the recruitment process and applicants will receive consideration for employment whatever the gender, marital status, religion, age, color, sexual orientation, nationality or disability, …