Quality Assurance Specialist – GMP & Compliance

Eurofins Group; Netherlands; Remote; EUR 42,000 - 64,000; Part time

Benefits offered by this job

Vacation days

Travel allowance

Pension scheme

Good Habitz training

Job summary

The Quality Assurance Officer position at Eurofins Bactimm in Nijmegen focuses on maintaining laboratory quality and compliance with GxP, ISO, and internal standards. The role involves managing deviations, CAPA, audits, and documentation control to support regulatory compliance.

Based in the Netherlands for a 32-hour work week, you will contribute to QA improvements, change control, and preparedness for inspections, while collaborating with a dedicated team.

Qualifications

• Bachelor’s degree or above in (bio) Chemistry, Biotechnology, (bio) Pharmacy, (molecular) Biology or related field OR a MBO degree with at least 3 years of experience.
• Minimum 1 year of experience in the (bio)pharmaceutical industry and in a quality oriented environment (GMP/GLP/ISO).
• Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH) preferred.

Responsibilities

• Manage and assess deviations, changes, complaints, OOS, and CAPA in accordance with GMP guidelines.
• Maintain and monitor the change control and deviation systems.
• Perform routine quality assurance tasks according to SOPs and quality standards.
• Contribute to the assurance of the quality system based on regulatory requirements and changes.
• Participate in QA initiatives and improvement projects.
• Train personnel on GMP and quality procedures.
• Conduct internal audits, self inspections and support external inspections.

Skills

GxP compliance

Audits

Team player

Regulatory knowledge

Education

Bachelor's degree in bioscience

MBO with 3+ years experience

Tools

SOPs

QA documentation systems

Job description

The Quality Assurance Officer position at Eurofins Bactimm in Nijmegen focuses on maintaining laboratory quality and compliance with GxP, ISO, and internal standards. The role involves managing deviations, CAPA, audits, and documentation control to support regulatory compliance.

Based in the Netherlands for a 32-hour work week, you will contribute to QA improvements, change control, and preparedness for inspections, while collaborating with a dedicated team.