Quality Engineer - Life Sciences, Leiden

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? Apply now!

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