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:
- You perform the quality review for process validation and other product-related validations such as analytical method, filtration, primary packaging and raw material validations. In this quality authority role you will work closely together with different project teams and different departments within the company as well as with R&D.
- You support regulatory submissions of the products by informing site colleagues of regulatory requirements and by providing the project details and the supporting validation data to GCMC. In this regulatory role you work closely together with global regulatory colleagues and R&D.
- You coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues.
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.
- Master degree in Life sciences (e.g. industrial pharmacist, biomedical sciences, bio-engineer,..)
- Minimum 2 years of experience in the pharmaceutical sector (or equivalent by acquiring a PhD), with experience or interest in validation, regulatory and quality.
- Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation
- Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset.
- Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
- Insight and understanding of shareholders needs and requirements.
- Dynamic, flexible, enthusiastic and eager to learn
- Takes initiative and ownership to deliver on time without compromising on quality
- Ability to work under minimal supervision and in a team (team player as well as team leader, depending on the situation)
- Fluent in written and spoken English and Dutch
- A balanced salary package based on your capabilities and experience, including meal vouchers.
Existing right to work in Europe required ( please read job spec in full before applying ).
Vacancy number : 16827