Site Compliance Network Member

As a Site Compliance Network Member you have to 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:

• Perform the quality review for process validation and other product-related validations such as analytical method, filtration, primary packaging and raw material validations
• Support regulatory submission by informing site members of regulatory requirements and by providing the project details and the supporting validation data to GCMC
• Coordination the implementation of changes per market after Board of Health approval in cooperation with Supply Management members

• 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.
• Knowledge of drug regulations and regulatory guidance of leading agencies (EMA, FDA) is a strong asset
• 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

• Challenging projects based on your interests and skills
• Personal follow-up and clear, transparent communication both before and after commencement of employment
• Possibility to follow extra training
• Inspiring network events and legendary after work drinks
• Strong network of industry leading clients
• Expertise within IT, Engineering and Life Sciences
• A flying start for every junior, growth opportunities and possibility to share gathered knowledge for more senior employees

Bezoek pauwelsconsulting.com voor meer informatie over de vacature Site Compliance Network Member of solliciteer online op de vacature Site Compliance Network Member.

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