Quality Assurance Officer

At Eurofins Bactimm in Nijmegen, the QC Lab is part of the internationally operating Eurofins Scientific and provides a diverse package of microbiological analyses for raw materials and finished products for national and international clients in the pharmaceutical and medical device industry. The analyses include bioburden tests, sterility tests, growth promotion tests and indication of microorganisms.

As a Quality Assurance Officer, you are responsible for ensuring quality within the laboratory and operational processes. You will work according to GxP, ISO, and internal quality standards and play a key role in documentation control, audits, training, and compliance.

Your responsibilities include:

• 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 implementation of regulatory changes.
• Participate in and set up QA initiatives and improvement projects.
• Train personnel on GMP and quality procedures.
• Conduct internal audits, self-inspections and support external inspections, for example by regulatory authorities.
• Create and revise QA procedures and work instructions.
• Maintain the GMP documentation system and archive, including electronic systems.
• Support the creation, review, or updating of QA agreements.
• Manage documentation and compliance related to opiates and precursors.
• Ensure GxP compliance of personnel, validation studies, facility and equipment from a QA perspective.
• Act as deputy for the QA Manager.

Qualifications

We are looking for a Quality Assurance Officer with the following criteria:

• Bachelor’s degree or above in (bio) Chemistry, Biotechnology, (bio) Pharmacy, (molecular) Biology or related field, or an MBO degree with at least 3 years of experience.
• Minimum of 1 year of experience in the (bio)pharmaceutical industry.
• Minimum of 1 year of experience in a quality-oriented environment (GMP / GLP / ISO).
• Organized, structured and accurate.
• High quality awareness.
• Proactive and customer-orientated team player.
• Fluency in Dutch or English; knowledge of both is preferred.
• Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH).
• Knowledge of (micro-)biological QC testing is preferred.
• Located in the Netherlands within reasonable distance of the site in Nijmegen and in possession of a valid work permit.

What Eurofins Bactimm offers

This position is based at Eurofins Bactimm in Nijmegen. You will join a close-knit team where collegiality and collaboration come first, in a responsible and challenging position with room for your own ideas and input.

• Flexible working hours.
• 25 days of vacation, with the option to purchase 7 additional days.
• Travel allowance of 23 cents net per kilometer, or full reimbursement of public transport expenses via NS Business Card.
• Participation in a pension scheme with 50% contribution by Eurofins.
• A monthly choice budget balance of 8.95% of gross salary, including holiday pay and a year-end bonus, which can be paid out or used for benefits such as extra days off.
• Discount on additional health insurance.
• Tax benefit via FiscFree when purchasing various products and services via gross salary, such as a bicycle, sports contribution, fitness, mobile telephony, computers and tablets or a weekend away.
• Professional training and opportunities for training and development.
• Training options via the online learning platform Good Habitz.
• Diverse developmental opportunities within the organization.
• A large client portfolio that ensures a lot of diversity in your work.

Working at Eurofins Bactimm offers the flexibility and personal touch of a medium-sized and dynamic company, while also allowing you to benefit from having Eurofins as a parent company.