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Regulatory and validation quality associate - Belgium, Netherlands
Posted on : 07 April 2017
Regulatory and validation quality associate
In this role you will be the quality reviewer of validation and will support new product registration activities of the assigned products. You will work in cross-functional teams and collaborate with external parties including R&D and Global Chemistry, Manufacturing & Controls (GCMC) colleagues in order to support the introduction of new products in the site.
- You will be quality authority for process validation and underlying product-related validations such as analytical method, filtration, primary packaging and raw material validations.
- You will assist in coordinating the implementation of new products in the plant, e.g. the product flow, the testing protocols, release process etc.
- You will work closely with subject matter experts in the manufacturing site and GCMC colleagues to support regulatory submissions of the new products.
- 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.
- Specific skills:
- 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 stakeholders’ 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 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.