1. QA Release Engineer
He/she is mainly responsible for preparing and/or performing market and distribution release of medicinal products and medical devices and for providing administrative support to the QP(s) performing batch certification. He/she is also responsible for the maintenance of the applicable procedures and compliance to the current legislation, and for deviation management within his/her area of responsibility.
- Degree in Life Science or equivalent through experience (minimum of 5 years)
- Basic knowledge of GMP/GDP and work experience in a quality organization
- Excellent communication and diplomacy skills
- Excellent administrative management skills
- Eye for detail, accuracy and punctuality
- Good sense of organization, planning, priority setting and initiative
- Dutch & English
2. Qualified Person
The QP maintains the Company’s Manufacturing License and observes that the Company’s medicinal products are solely released in accordance with applicable legislation, relevant guidelines and requirements of local competent authorities, technical agreements. It is the overall responsibility of the QP, in collaboration with the Manufacturing License holder, to ensure that products of insufficient or dubious safety, quality and/or efficacy are not released. Any delegation of tasks to colleagues does not limit the responsibility of the QP.
- You obtained a Master Degree in Industrial Pharmacy and you obtained a QP number
- You are fluent in Dutch and English
- You value accuracy and are able carefully to read, synthesise and interpret legal texts
- You have a strong analytical mind allowing you to focus on detail to and draw up accurate descriptions and summaries
- You dispose of excellent communicative skills, are assertive and dynamic. Also, you like to work in a team
- You are comfortable dealing with changing priorities and deadlines
- You have a strong sense of initiative and organisation
3. Compliance Scientist
As a compliance scientist, you act as a liaison between the registration department, R&D and the plant. You oversee the compliance status of the products made on site by evaluating registration dossiers, evaluating changes to controlled manufacturing and QA systems, trending stability data (and other data) and implementing new GMP & industry regulations and regulatory requirements.
- Master’s degree or PhD in Biomedical Sciences, Pharmaceutical Sciences, Bioengineer, etc.
- Strong interest in statistics and working with numbers
- Critical and analytical mindset
- Creative and problem solving thinking
- Autonomous and willing to take ownership
- Team player
- Fluent communicator both orally and in writing
- Excellent knowledge of English and Dutch.
4. Project Engineer
You are responsible for performing urgent quality checks, process qualification, validation and risk assessments and preparing corresponding documentation. You implement changes, work on introduction of new products on site and you write/review protocols.
- Master’s degree /PhD in a scientific direction
- A first experience in sterile drug production, project management or process validation in a GMP environment are a plus
- Team player with strong communication skills: close collaboration with stakeholders, your team and colleagues in Production, Quality and Supply
- Assertive, strategic, strong reasoning and analytical skills
- You have a dynamic and enthusiastic personality and you are willing to continuously learn
5. Lab Technicians
You independently perform tests (raw materials, semi-finished and finished products) and report according to legal and applicable cGMP guidelines. You ensure that your knowledge of cGMP, procedures and safety is up-to-date.
- Bachelor’s degree in Chemistry/Pharmaceutical and Biological Laboratory Techniques or equivalent
- Practical experience with lab analysis: non-chromatographic (analysis of raw materials, SDS, ELISA...) and/or chromatographic tests (HPLC, UPLC, GC...)
- Strong interest in working in a GMP environment. Experience within a GMP environment is a strong asset
- Experience with PC software applications (MS Office, LIMS) is an added value
- Strong affinity for carrying out routine analyses
- You can interpret and report results accurately
- You can work both in a group and independently
- Flexible in terms of tasks and schedule (shifts)
- You are fluent in Dutch and English. Other languages are a plus