General information
Quality Engineer
The Quality Engineer is responsible for supporting both the Quality Control (QC) team and the Quality Assurance (QA) team, in all quality-related activities, ensuring compliance with regulatory standards and internal procedures. The quality engineer is formally part of the QC-team.
Your tasks
- Draft and manage QC-related quality records, including OOS, deviations, CAPAs, and change controls.
- Conduct root cause investigations and ensure timely and effective closure of quality issues.
- Perform peer reviews of executed assay documentation to ensure accuracy and compliance.
- Ensure compliance and completeness of QC SOPs and work instructions.
- Manage all documentation, results and samples with regards to outsources stability programs
- DocController of the eDMS: Manage document records, workflows, etc for all HALIX departments.
- Print hard copies, such as log books.
- Hard copy archival
- Support incoming goods management
- Support assessment of supplier change notifications
- Environmental monitoring of clean rooms
- Testing of water samples
- QA Document control, document issuing, and archiving
- AD hoc QA activities
You have
- MBO/HBO degree in related field.
- A minimum of 2 years of experience in the pharmaceutical and/or biotech, preferably in a quality unit.
- Advanced knowledge of GMP, GDocP and data-integrity.
- Experience in writing quality records
- Experience in reviewing analytical assay documentation
- Good command of English language, both verbally as in writing.
- Excellent technical writing skills.
Who are we looking for?
We are looking for a candidate who is committed to continuous professional development, is analytically strong, and works in a results‑oriented way. You take ownership of your work, plan and organize effectively, and work efficiently toward set goals. Additionally, you are a team player who actively contributes to strong collaboration.
Our offer
- You will be part of a steadily growing and dynamic biopharmaceutical company offering a great environment for self-starters.
- A culture that is characterized by entrepreneurial spirit and close and transparent communication. The patient’s well-being is always our top priority. This combination is the basis for an interesting and challenging environment.
- You will be working in our dynamic headquarters in Leiden.
- Being part of a company that is focused on excellence in GMP Manufacturing.
- A competitive salary that matches your responsibilities and experience.
Your application
We look forward to hearing from you! We are interested in your CV, but we also want to find out more about your ambitions, your personality and what drives you to apply. So be sure to include a brief cover letter telling us why you are a match for this position. The application process consists of an introduction by the Recruiter, two interviews either via video call or live at our office in Leiden with the Hiring Manager and/or a Department Specialist followed by contract negotiations. Depending on the vacancy, an assessment could be part of the process.
Important notice to search firms and recruitment agencies
HALIX does not accept unsolicited approaches from recruitment agencies and/or search firms (such as, for instance, the sending of resumes) for any job posted on this or a referring website. All recruitment agencies and search firms are required to contact HALIX Recruitment via recruitment@hal-allergy.com to enquire about a potential recruitment or search agreement with HALIX.
HALIX, Bioscience as a Service
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We support our customers with the development & commercialization of biologics enabling the treatment & prevention of life threatening conditions such as cancer, COVID-19, influenza and other infectious diseases. Our state of the art GMP manufacturing facilities and our experienced and dedicated team of people ensures manufacturing capabilities which meet the highest quality standards, a service oriented way of working and a flexible mindset. If you too would like to become part of an innovative and challenging contract development and manufacturing organization (CDMO), then this is a perfect opportunity!
HALIX is headquartered in Leiden, where all disciplines work under one roof, from development to sales. We work in an informal, culturally diverse organization with room for growth and continued personal development. HALIX is located in the middle of the thriving and energetic Leiden Bio Science Park, the largest innovation district of the Netherlands in the field of Life Sciences & Health. The central train station and the ancient city center of Leiden are just a 5 minute bike ride away from our office.
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