Non-Conformities Specialist

Avertim Netherlands; Amsterdam; On-site; EUR 65,000 - 90,000; Full time

Job summary

Avertim Netherlands seeks a Non-Conformities Specialist to support GMP compliance in Amsterdam. You will manage NCs, lead investigations, and drive CAPAs across QA, Regulatory Affairs, and Production.

You will collaborate with cross-functional teams to ensure regulatory standards such as FDA and EMA are met, contribute to continuous improvement, and deliver robust NC and CAPA processes, SOPs, and training.

Qualifications

• Master’s degree in Engineering, Pharmacy, Life Sciences, or related field.
• Minimum of 3 years of experience in Pharmaceuticals, Biotech, or Medical Devices.
• Knowledge of GMP regulations (FDA, EMA).
• Hands-on experience with NC management, CAPA systems, deviation investigations, RCA, and change controls.
• Fluent in English; Dutch language skills are a plus.

Responsibilities

• Lead end-to-end management of NCs: investigation, documentation, and closure.
• Drive CAPA definition, implementation, and follow-up.
• Perform root cause analyses and risk assessments to prevent recurrence.
• Manage deviation investigations ensuring documentation quality.
• Coordinate change controls related to NC and CAPA activities.
• Ensure GMP, FDA, EMA compliance in all quality activities.
• Collaborate with Production, Quality Control, QA, and Regulatory Affairs.
• Support internal audits and regulatory inspections.
• Maintain and improve SOPs, NC workflows, CAPA systems, and GMP documentation.
• Provide GMP training and guidance to operational teams.

Skills

Planning & organization

Communicating & influencing

Analytical mindset

Lean Six Sigma

English (Fluent)

Dutch language knowledge

Education

Master’s Degree in Engineering, Pharmacy, Life Sciences, or related field

Job description

Avertim Netherlands is currently looking for Non-Conformities Specialists 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 of the largest players in the Life Sciences sector.

As an NC Specialist, 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 lead investigations, perform root cause analyses, and implement corrective and preventive actions (CAPAs) while ensuring full compliance with regulatory standards.

Key responsibilities

• Lead the end-to-end management of Non-Conformities (NCs), including investigation, documentation, and closure
• Drive and ensure timely and effective CAPA definition, implementation, and follow-up
• Perform root cause analyses (RCA) and risk assessments to prevent recurrence of deviations
• Manage and support deviation investigations, ensuring quality and completeness of documentation
• Oversee and coordinate change controls related to NC and CAPA activities
• Ensure compliance with GMP, FDA, EMA, and other regulatory requirements in all quality-related activities
• Collaborate with Production, Quality Control, QA, and Regulatory Affairs teams to strengthen quality processes
• Support and participate in internal audits and regulatory inspections
• Maintain and continuously improve SOPs, NC workflows, CAPA systems, and GMP documentation
• Provide GMP training and guidance to operational teams to increase awareness on NC and CAPA processes

Your background

• Master’s Degree in Engineering, Pharmacy, Life Sciences, or related field
• Minimum of 3 years of experience in Pharmaceuticals, Biotech, or Medical Devices
• Knowledge of GMP regulations (FDA, EMA)
• Strong hands-on experience with:

NC management

CAPA systems

Deviation investigations

Root cause analysis methodologies

Change control processes

Skills

• Planning & organization – Ability to structure and manage workload effectively, set priorities, and meet deadlines
• Communicating & influencing – Clear, structured communication and strong stakeholder alignment skills
• Strong analytical mindset with a focus on problem-solving and continuous improvement
• Familiarity with Lean, Six Sigma, or structured RCA methodologies is a plus
• Fluent in English, Dutch is a plus
• Valid Dutch working permit (no sponsorship 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 their gender, marital status, religion, age, color, sexual orientation, nationality or disability, …