GMP Quality Engineer – CAPA & NC Resolver (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 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.