Validation and Regulatory Quality Associate

15-12-2018 puurs
company profile

Our client, who is a pharmaceutical giant in the industry, is seeking a dynamic Validation and Regulatory Quality Associate to join their team to support the commercial launch of new (biological) drugs.

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 and collaborate with R&D, global regulatory colleagues and the supply department. This in order to support the introduction of new products in the site.

Are you looking for a permanent contract at Ausy, a project contract or do you want to work as a freelancer? Don't hesitate to contact me, because it's all possible at Ausy!

Apply here for this exciting job: or 03 200 28 01.

job description

Are you seeking to work with innovative products, in an exciting and fast evolving environment? Are you the one to ensure that the manufacturing and testing of these products is appropriately qualified and in compliance with regulations? Then this job is perfect for you!

How will you ensure that the manufacturing and testing practice at the site is appropriately qualified and in compliance with the regulations?

- You perform the quality review for process validation and other product-related validations.
- Your skills as a team player will come in handy in this quality authority role when working closely together with different project teams and different departments.
- Your organizational talent ensures fluent coordination of the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues.
- 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 to the right department.

your contribution

If you can check off each of the following skills, you're the person I'm looking for!

- You have a Masters degree in Life Sciences (industrial pharmacist, biomedical sciences, bio-engineer ...).
- Your minimum of 2 years experience in the pharmaceutical sector OR equivalent by acquiring a PhD with an interest in validation, regulatory and quality will be valuable.
- Your scientific knowledge and strong analytical skills are necessary when making sound quality assessments of project strategy and documentation.
- Your knowledge of drug relations and regulatory guidance of leading agencies is a strong asset.
- You have good negotiation and influencing skills.
- Your knowledge of English and Dutch will ensure smooth communication with all parties involved.
- Your time management skills makes sure you take initiative and ownership to deliver on time without compromising on quality.
- Your interpersonal and communication skills, eye for detail and accuracy will convince the hiring manager to choose you as his next colleague!

what do we offer?

As an answer to your high performance & flexibility, Ausy offers you an interesting salary package, with some interesting extra's like:

- Meal vouchers of €7
- Net representation cost of €50
- Hospitalization insurance
- Car + unlimited fuel card OR home-work compensation
- 32 holidays
- End-of-year bonus
- Pension plan
- ECO vouchers
- Opportunities to follow trainings

engineer (m/f)
employment type
full time, freelance
contract type
immediate permanent employments
your Randstad contact
Laurence Teerlynck 03 201 39 26
03 201 39 26