A new plant for the production of cell culture media is being built at our location in Tilburg. Cell culture media are raw materials for the biopharmaceutical industry, where they are used for the production of medicines or vaccines. For this new production facility we have vacancies for two QC Analysts in the Quality Systems / Regulatory Affairs (QS/RA) department.
The QS/RA section is responsible within LSM for all activities relating to quality. This is for example the approval of raw materials and release of finished products and all tests on these materials, but also supplier evaluations, deviations during production and change control. As a QC Analyst, you are responsible for carrying out tests and inspecting products, processes, raw materials and intermediate products to ensure that they meet the correct specifications.
- Independently carrying out tests on raw materials, intermediate and end products to ensure the quality of the material, as well as carrying out tests for monitoring the cleanroom (particles, microbial) and water quality;
- Performing QC (microbial, chemical and stability) tests;
- Analysing and reporting results;
- Supporting the writing of procedures for quality initiatives;
- Assisting in ensuring quality throughout the QC lab: test methods are accurate and up-to-date and SOPs are clear and meaningful;
- Performing, monitoring, maintaining and reporting on QC equipment and QC method validation;
- Developing background knowledge of applicable QC methods.
- A completed MBO-4 degree in microbiology, analytical chemistry or biochemistry;
- Minimum of 6 years' relevant work experience, preferably in a GLP environment or QC lab in the medical, pharmaceutical, biotechnology or similar industry;
- Relevant experience with various QC techniques such as pH, conductivity, bioburden, endotoxin, etc;
- Preferably knowledge and understanding of applicable FDA and EU GMP guidelines, USP and EP compendia and ISO 13485;
- Experience with working according to protocols is an advantage;
- Good command of the Dutch and English language orally and in writing;
- A Certificate of Good Behaviour must be submitted for acceptance.
We are looking for
Colleagues who consider quality of paramount importance. You are critical, analytically strong and able to communicate constructively with various stakeholders. You are disciplined in working according to fixed protocols. After a short familiarization period, you are able to carry out your tasks independently. Working in a team is also something you do well. The start-up of a new department goes hand in hand with hectic activity, deadlines and possibly changing priorities. You are able to deal with this and ensure that your work is carried out as agreed.
Where are you going to work
FUJIFILM Manufacturing Europe B.V. is one of the largest production facilities outside of Japan. Here we are responsible for the production of photo paper, offset plates and membranes with about 700 employees. In addition, we are expanding with a new plant for the healthcare industry where we will produce cell culture media. In the Tilburg Research Laboratory we are continuously developing new technologies and products. Next to this a part of the European headquarters is located in Tilburg. This company is responsible for procurement, finance, IT, logistics and customs matters.
The Quality Systems / Regulatory Affairs department currently consists of 10 people. The Life Science Manufacturing department is a growing organisation and so will the QS/RA department in the future.
At Fujifilm, the employees are the most important capital. We want people to feel at home in our company. We provide good terms of employment and look at the development of talent. In addition, we invest in training, consider development opportunities and think about the future is an annually recurring theme within our human resources policy.
Next to this:
- A 40-hour working week with the possibility to arrange your working hours flexibly;
- An above-average salary, depending on education and experience;
- A good bonus scheme;
- 27 vacation days;
- 12,5 LTR days
- A travel and expense allowance;
- A good pension plan;
- A collective health insurance;
- Good training and development opportunities;
- And nice other fringe benefits such as participation in the bicycle plan or discount on trips.
You will be based in Tilburg.
Would you like to increase your career opportunities within an innovative, high-tech and international company? Then send your CV and motivation letter stating "RA-1058 QC Analysts" to email@example.com
If you have any questions, please contact Heidi Franken, Sr. Supervisor at +31(0)6 5237 4182 or visit www.fujifilm.com/ef/nl for more information about our organization.
Acquisition in response to this vacancy is not appreciated.