Functieomschrijving

Become our Specialist QA / Qualified Person in Amgen sa-nv (Diegem, Belgium) and play an important role in ensuring that our produced medicines meet the highest standards and align with regulatory requirements, to ultimately reach our patients in Belgium and Luxembourg. The purpose of the role is to be part of the International Distribution & Quality, in charge of creating, maintaining the quality management system of Amgen sa-nv. Join us in our commitment to quality, and together, let's elevate patient care. This is your chance to thrive in an environment where quality is at the heart of everything we do.

Vereisten

- Master in Pharmaceutical Sciences - Registration on the list of Qualified Persons as required per RD 14/12/2006 - Minimum 3 years' experience in Quality Assurance in the pharmaceutical, biotechnology, or medical devices industry in affiliate setting - Previous practical experience in Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) - Knowledgeable and skilled to fulfill the requirements of EU directive 2001/83/EC article 49 (Qualified Person) - Knowledge on Belgian and Luxembourg regulations in relation to Manufacturing, Importation, Wholesale Distribution, Import, Export and Foreign trade , Guidelines on Good Manufacturing Practice (EU GMP) (Eudralex Volume 4), Guidelines on Good Distribution Practice (EU GDP) of medicinal products for human use (2013/C 343/01), European Community Directive D2001/83/EC relating to trade abroad activities, European Falsified Medicines Directive (2011/62/EU), and the European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products (92/25/EEC) - Ability to problem solve and make scientific risk-based decisions - Demonstrated proficiency in written and verbal communication skills (including technical writing and presentations) with the ability to effectively communicate and collaborate with production and technical staff - Fluency in English; Dutch and French as beneficial

Must-have

• Master
• Belgian and Luxembourg regulations in relation to Manufacturing, Importation, Wholesale Distribution, Import, Export and Foreign trade

  Good Distribution Practice (GDP)

  European Community Directive D2001/83/EC relating to trade abroad activities

  European Pharmaceutical Directive related to Wholesale Distribution of Medicinal Products (92/25/EEC)

  Good Manufacturing Practice (GMP)

  Guidelines on Good Distribution Practice (EU GDP) of medicinal products for human use (2013/C 343/01)

  European Falsified Medicines Directive (2011/62/EU)

  Guidelines on Good Manufacturing Practice (EU GMP) (Eudralex Volume 4)

  EU directive 2001/83/EC article 49 (Qualified Person)
• Engels

Nice-to-have

• problem solving

  scientific risk-based decisions

  verbal communication skills
• Nederlands

  Frans

Wij bieden

We are a Biotech company with high-quality standards, and this is embedded in our culture throughout the company. This is your chance to thrive in an environment where quality is at the heart of everything we do.

Groei met ons mee

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