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:
- 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 QA system initiatives and improvement projects.
- Train personnel on GMP and quality procedures.
- Conduct (internal) audits and support external inspections (e.g., by regulatory authorities).
- Execute, report, and follow up on self-inspections.
- 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.
- Oversee the implementation of new equipment from a QA perspective.
- Ensure compliance in equipment metrology, including documentation.
- Review pest control reports and other facility-related quality documents.
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- a 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 biological process development and manufacturing is preferred.
Additional Information
Eurofins BioPharma Product Testing Leiden B.V.: A world of possibilities
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 fulltime contract);
- Professional training and opportunities for training and development;
- 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:
- Diverse developmental opportunities within the organization;
- A large client portfolio ensures a lot of diversity in your work.
About the Company
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 productspecific methods in close collaboration with our clients, and we also offer smallscale manufacturing services.
We have a professional team consisting of a mix of young and experienced people with different backgrounds and experiences. Together we strengthen global healthcare and help advance the pharmaceutical product quality and patient safety worldwide.