Quality Assurance Officer
Eurofins BioPharma Product Testing Leiden B.V., part of the globally operating Eurofins Scientific network, is a leading GMP-certified contract laboratory serving the (bio)pharmaceutical industry. Based at the Leiden Bio Science Park, we provide a comprehensive range of microbiological, viral, chemical, and physical quality control testing for pharmaceutical raw materials, intermediates, and finished products. In addition to our standard test packages, we develop and validate product-specific methods in close collaboration with our clients, and we also offer small-scale manufacturing services.
As a Quality Assurance Officer, you are responsible for ensuring quality within our 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 managing and assessing deviations, changes, complaints, OOS, and CAPA in accordance with GMP guidelines; maintaining and monitoring the change control and deviation systems; performing routine quality assurance tasks according to SOPs and quality standards; contributing to the assurance of the quality system based on regulatory requirements; participating in QA system initiatives and improvement projects; training personnel on GMP and quality procedures; conducting internal audits and supporting external inspections; executing, reporting, and following up on self-inspections; creating and revising QA procedures and work instructions; maintaining the GMP documentation system and archive; supporting the creation, review, or updating of QA agreements; managing documentation and compliance related to opiates and precursors; overseeing the implementation of new equipment from a QA perspective; ensuring compliance in equipment metrology; and reviewing pest control reports and other facility-related quality documents.
We are looking for a Quality Assurance Officer with a Bachelor’s degree or above in (bio) Chemistry, Biotechnology, (bio) Pharmacy, (molecular) Biology, or a related field, or an MBO degree with at least 3 years of experience. The ideal candidate will have a minimum of 1 year of experience in the (bio)pharmaceutical industry and a minimum of 1 year of experience in a quality-oriented environment (GMP/GLP/ISO). The candidate should be organized, structured, and accurate, with high quality awareness, and be a proactive and customer-oriented team player. Fluency in Dutch or English is required; knowledge of both is preferred. Knowledge of GMP quality systems and regulatory requirements (Eudralex, ICH) is essential, and knowledge of biological process development and manufacturing is preferred. The candidate should be located in the Netherlands within reasonable distance of our site in Leiden.
This position is based at Eurofins BioPharma Product Testing Leiden on the Bio Science Park in Leiden. We have a close-knit team where collegiality and collaboration come first. We offer a responsible and challenging position within the team with room for your own ideas and input. Eurofins BioPharma Product Testing Leiden also offers a competitive salary, flexible working hours, 25 days of vacation with the option to purchase 7 additional days (based on a full-time contract), a travel allowance of 23 cents net per kilometer (with full reimbursement for public transport via NS Business Card), participation in a pension scheme with 50% contribution by Eurofins, a choice budget balance of 8.5% of your gross salary (including holiday pay and a year-end bonus), discount on additional health insurance, tax benefits via FiscFree for various products and services, professional training and development opportunities, and training options via the online learning platform Good Habitz.
Working at Eurofins BioPharma Product Testing Leiden offers you the flexibility and personal touch of working in a medium-sized and dynamic company, whilst also allowing you to benefit from having Eurofins as a parent company. Our ambitious growth plans provide ample opportunities for our employees, including diverse developmental opportunities within the organization and a large client portfolio that ensures a lot of diversity in your work.