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Site Compliance Officer
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:
* 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 Pfizer Puurs as well as with R&D.
* support new and/or ongoing regulatory submission of 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 Pfizer colleagues and R&D.
* coordinate the implementation of changes per market after Board of Health approval in cooperation with Supply Management colleagues.
* 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:
o Scientific knowledge and strong analytical skills to make sound quality assessments of project strategy and documentation
o Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset.
o Ability to communicate effectively verbally and in writing, good negotiation and influencing skills.
o Insight and understanding of shareholders needs and requirements.
o Dynamic, flexible, enthusiastic and eager to learn
o Takes initiative and ownership to deliver on time without compromising on quality
o Ability to work under minimal supervision and in a team (team player as well as team leader, depending on the situation)
o Fluent in written and spoken English and Dutch