For one of our clients in Puurs, we are looking for a "Validation and Regulatory Quality Associate".
Our client located in Puurs (Antwerp) is among the world's largest aseptic drug manufacturing sites and is part of a biotech manufacturing network.
The site has a strong base of established drug products such as sterile antibiotics, prostaglandins and corticosteroids for global distribution, as well as innovative drugs and vaccines. It is also our client's standard launch site for new biotechnological drugs that have shown promising results in clinical trials.
The Regulatory and Validation Department located in Puurs (Antwerp) is seeking a dynamic Validation and Regulatory Quality Associate to join our team..
In this role you will be responsible for validation and product registration activities of the assigned products. You will work in cross-functional teams with different Puurs departments (manufacturing, labs, ..) and collaborate with R&D, global regulatory colleagues (Global Chemistry, Manufacturing & Controls (GCMC)) and the supply department in order to support the introduction of new products in the site.
Are you seeking to work with innovative products, in an exciting and fast evolving environment? Join the team!
You ensure that the manufacturing and testing practice at the site is appropriately qualified and in compliance with the regulations (GMP, ICH, ..) and with the description in the submitted registration dossiers.
To accomplish the above:
Do the above responsibilities fit you like a glove?
Upload your CV and motivation letter via the "apply now" button and you can expect feedback from us soon.
If something is not entirely clear, you can reach out to us by telephone of course.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 16827