Qualified Person at HAL Allergy
HALIX is a fast growing, biopharmaceutical contract development and manufacturing organization (CDMO) focused on viral vector and recombinant protein products. We have recently built a state-of-the-art GMP manufacturing facility at the Bio Science Park in Leiden that is getting filled with exciting new vaccines, antibodies and protein products. At HALIX, 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.
Currently we are working on the production of a leading COVID-19 vaccine candidate. If you too would like to contribute to this challenging and fulfilling activity and become part of an inspiring biotech services company, then this is a perfect opportunity for you.
Tasks and Responsibilities
The Qualified Person is ultimately responsible for the release of investigational medicinal products to the client or to the clinic.
The Qualified Person will represent HALIX to authority bodies and client and will have full quality oversight and control in projects.
- Focal point of contact with regulatory authorities, such as The Dutch Health Inspectorate (IGJ) and/or FDA to establish and maintain the compliance status
- Batch disposition and certification of biological Drug Substance Products and/or Drug Products in accordance with EU/FDA-directives
- Batch certification and release of final product for use in clinical trials in accordance with the relevant IMPD/IND
- Direct point of contact with clients to manage quality topics
- Act as an internal Quality consultant on applicable regulations and related topics and how to translate these into daily practice
- External auditing at service providers and suppliers and contract partners as part of vendor qualification
- Internal auditing
- Investigation of Product Quality Complaints and lead product recalls.
- Academic degree in a relevant field, such as pharmacy, chemistry, biology, Biotechnology
- Eligible as a Qualified Person by IGJ
- 3 years of experience in biotechnology manufacturing and testing
- Broad knowledge of and experience with EU/FDA GMP guidelines and inspections
- Experience with Lean management and 6 Sigma methodology
Personal & Professional Skills
- Natural authority
- Experience with communication on all organisational levels including authorities and Senior management
- Decisive, analytical and accurate
- Ability to be creative, thinking out of the box
- Good knowledge of English and Dutch in speaking and writing. German advantageous
- We offer you a highly dynamic job in an interesting environment
- You will be working from our headquarters in Leiden, where the products are produced on site.
- HALIX offers great benefits including a competitive salary and contribution to pension and health insurance.
Applications and more information
Interested? We look forward to receiving your application. To apply, please click the "Apply" button below to the right where you will be prompted to upload your CV first.