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QA Engineer/Junior Qualified Person à Ghent

Job DescriptionEurofins 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

Description du poste

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).


Additional Information

  • Work in a fast growing organization.
  • A position with responsibility within a dynamic company.
  • Personal development through learning on the job and additional external trainings.
  • A market oriented compensation.

Informations supplémentaires

Statut
Inactif
Formation requise
Autres
Lieu
Ghent
Heures de travail par semaine
8 - 40
Type de Contrat
Temps plein/ CDD
Secteur
Ingénieurie mécanique
Permis de conduire BE/EU exigé
Non
Voiture exigée
Non
Lettre de motivation exigée
Non
Langues
Français

Ingénieurie mécanique | Temps plein/ CDD | Autres

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