Qualified Person at Eurofins PROXY Laboratories
Eurofins Scientific is an international life sciences company, which provides a unique range of analytical testing services to clients across multiple industries. The Group believes it is the world leader in food, environment, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and for supporting clinical studies. In addition, Eurofins is one of the leading global emerging players in specialty clinical diagnostic testing.
In 2018, Eurofins generated 4.2 billion Euro proforma turnover in 800 laboratories across 47 countries, employing about 45.000 staff.
Business Unit Eurofins Manufacturing in Leiden is part of the international operating Eurofins and is a GMP certificated service organization, specialized in chemical- and physical testing. The organization performs next to stability- and validation studies also aseptic products of clinical material from the clean room. The Business Unit exists of 11 employees, among which a manager, a project manager, a team leader and a qualified person.
The Business Unit Manufacturing is specialized in Contract Manufacturing: aseptic fill of medication for pre- clinical and phase I and II Clinical trials. As well as small scale fill of commercialized products.
Your main responsibilities are:
- You implement, maintain and manage a GMP compliant Quality Management System for manufacturing and quality control of biological drug substances and related final products based on applicable regulations and guidelines.
- You manage the CAPA system: changes, deviation, non-conformities.
- You manage, support and coordinate risk assessments.
- You manage the supplier qualification process (materials and services).
- You support and review the qualification of production equipment, test equipment and cleanroom facility.
- You lead audits and inspections.
- You will review and approve batch records.
- You will release batches of biological intermediate products, drug substances and related final products (Investigational Medicinal Products).
- As a Qualified Persons you certify final products (Investigational Medicinal Products).
- You promote the awareness of quality, regulatory and customer requirements throughout the company.
- Master of Science degree in pharmaceutical sciences, chemistry, biochemistry or related discipline
- You are registered as a Qualified Person
- 10 years of quality assurance experience in the pharma and/or biotech industry.
- Knowledge of GMP quality system and regulatory requirements (Eudralex, ICH)
- Knowledge of biological process development and manufacturing is a real asset
- Excellent organization, facilitating and coordination skills. Ability to work independently as well as a member of a team in a dynamic environment
- Strong decision making and problem-solving skills
- Leadership skills
- Excellent oral communication, reporting and presentation skills
- Fluent in Dutch and English, written and spoken.
Manufacturing and Eurofins: A world of possibilities
This position is based at Business Unit Eurofins Manufacturing (part of Eurofins PROXY Laboratories B.V.) on the Bio Science Park in Leiden. We highly value our strong team spirit and encourage collaboration between colleagues.
Business Unit Eurofins Manufacturing offers a wide range of personal and professional possibilities:
- A responsible and challenging position within the team;
- Plenty of room for your own ideas and input;
- Specialist training and a range of opportunities for personal and professional development;
- Flexible working hours;
- Good salary and benefits.
Working at Business Unit Eurofins Manufacturing 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 the motivated employees:
- Plenty of opportunities for growth;
- Varied work where you are in regular contact with other companies and scientists within the Eurofins group ;
- A broad customer portfolio ensuring a lot of diversity in your work.
Would you like to know more?
For questions regarding the position, please contact our the Human Resources Department at 071 524 40 80.
Acquisition for this vacancy is not appreciated.