Eurofins

QA Engineer/Junior Qualified Person (BB-94F1B)

Trouvé dans: Neuvoo BE

Description:

Company Description

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate. Eurofins believes it is a global leader in food, environmental, pharmaceutical and cosmetics products testing and in agroscience CRO services. It is also one of the global independent market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, CDMO, advanced material sciences and in the support of clinical studies.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to over 50,000 staff across a network of more than 900 independent companies in over 50 countries and operating more than 800 laboratories. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products, as well as providing innovative clinical diagnostic testing services, as one of the leading global emerging players in specialised clinical diagnostics testing.
In 2019, Eurofins generated total revenues of EUR € 4.56 billion, and has been among the best performing stocks in Europe over the past 20 years.

Eurofins CDMO is one of the leading CDMOs in Europe providing high-quality, customized drug development solutions for specialty and biopharma clients. Our focus is to support clients on the earliest phases of their development pathway (from API to the clinical packaging).
Its Belgian subsidiary, Eurofins Amatsigroup NV, is based in Ghent, offering a complete drug development package for new drug entities (biological and chemical) up to early clinical phases to third parties to help them in speeding up the development and manufacturing of their drugs.

Job Description

Eurofins Amatsigroup Drug Product Business Unit wishes to enforce its Clinical Trial Manufacturing team with a QA Engineer/Junior QP .

  • Maintain and improve the Quality Management System for the GMP production and quality control of Investigational Medicinal Products (IMPs).
  • Ensure compliance of the production and quality control activities with applicable guidelines and regulations.
  • Support the qualification of production and test equipment.
  • Evaluate performed quality supportive activities like calibration, monitoring of clean rooms, cleaning of equipment.
  • You release raw materials, packaging materials and intermediate products.
  • You support the Qualified Person in the batch certification of produced IMPs.
  • You act as a back-up for the Qualified Person.
  • You participate in quality audits and inspections.
  • You manage and follow-up the CAPA system.
  • You will report to the QA Manager/Qualified Person.
  • Qualifications

  • A minimum of a Master Degree in Pharmaceutical Sciences with two (2) years of experience in a GMP pharmaceutical production environment or equivalent by experience.
  • Registered as Qualified Person at the Federal Agency for Medicines and Health Products (FAMHP).
  • You have knowledge of Quality Management in a regulated environment (Eudralex, ICH, FDA).
  • Experience in pharmaceutical product development is a surplus.
  • You are flexible, quality minded and problem solving.
  • You are fluent in English (written and spoken).
  • calendar_todayil y a 1 jour

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    info Full Time

    location_onGhent, Belgique

    work Eurofins

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