Validation and Regulatory Quality Associate
In this role you will be responsible for validation and new product registration activities of the assigned products. You will work in cross-functional teams with different departments (manufacturing, labs, ..) and collaborate with R&D, global regulatory colleagues 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? This is the job for you!
WHAT ARE YOUR RESPONSIBILITIES?
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 as well as with R&D.
- You support regulatory submission of the new products by informing site colleagues of regulatory requirements and by providing the project details and the supporting validation data. 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.
WHO ARE WE LOOKING FOR?
- 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
WHAT DOES QBD OFFER YOU?
- A young, dynamic company with a let’s go for it mind-set, a no-nonsense approach, and a culture of openness and transparency
- Personal and professional development through guidance, education and knowledge sharing
- A competence development model focused on your personal ambitions
- An attractive salary package, including a variety of extralegal benefits such as a company car, fuel card, mobile phone, etc.
Interested? Apply now by sending us your CV and motivation.