QA Associate Manufacturing 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.
As QA Associate Manufacturing you work to ensure the phase I, phase II and commercial products made meet all the quality requirements: safety, efficacy, potency and purity. This concerns both the requirements from the customer as the regulatory requirements.
The QA associate validates that the products comply with the product label claim and maintain the quality system.
As a QA Associate Manufacturing you will:
- Be responsible for on the floor quality oversight of the production of products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.
- Work with Project Managers and Operations organization to successfully transfer process from the client to GMP facility to manufacture products.
- Support drafting of standard operating procedures and batch records.
- Real time review of all documentation and reporting in support of process unit operations.
- Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
- Strive to reduce non-conformances in supported areas by proactively driving compliance.
- Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
- Other duties will be assigned, as necessary.
- A minimum of a Bachelor’s Degree in Engineering, Science or equivalent technical discipline is required
- Preferably four (4) years of experience in Quality Assurance related to manufacturing
- Experience in clinical quality, method development or Research & Development is preferred
- Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required
- Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing
- Excellent written and oral communication skills are required
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.