Quality Insurance Internship

il y a 7 jours


Brussels, Belgique Mithra Pharmaceuticals SA Temps plein

Overview:
Stage de 2-3 mois dans le département Assurance Qualité.

Projets 1 et 2: Q1-Q2 2024.

Projet 3: Q1-Q2-Q3-Q4 (?) 2024.

**Responsibilities**:
Trois propositions de projet:
**PROJET 1: Revue de la procédure "Gestion des partenaires".**

Le stage proposé ici est de revoir la procédure de gestion des partenaires. Actuellement, 3 procédures existent : une générale, une pour le département pharmacoviliance et une pour le département clinical operations. Des discordances existent entre les 3 procédures. De plus, les requis donnés par la procédure générale ne sont pas applicables dans tous les départements. L'objectif du stage est, d'une part, de réaliser des interviews avec chaque département pour connaitre leurs besoins, leurs requis, leur façon de fonctionner. Il faut également s'assurer de la compliance aux GxP. Après collecte des informations, le second objectif est d'écrire une procédure afin de répondre aux requis/besoins. Eventuellement, si la durée du stage le permet, une formation à tous pourrait également être proposée pour finaliser le travail.

**PROJET 2: Revue des procédures "Gestions des Change Control/Déviations/CAPA"**

**PROJET 3: Mise en place d'un e-QMS**

Le stage proposé ici est de travailler conjointement avec l'équipe IT/Qualif/Valid/CSV afin de donner les requis QA pour la mise en place d'un e-QMS (electronic quality management system). Le but d'un e-QMS est d'avoir à disposition tous les documents du système qualité à un même endroit, triés par type de documents, avec des flux d'approbation spécifiques ; ainsi qu'un module de formation du personnel à ces documents. La mise en place de ce système nécessite l'implication du département IT pour les aspects de faisabilité du système, du département QA pour les requis liés aux flux des documents et à leurs formations, et également tous les départements de Mithra pour savoir quels types de documents se trouvera dans cet e-QMS.

Il est fort possible que la durée du stage ne permette pas de voir l'aboutissement du projet. Toutefois, la contribution du stagiaire sera menée avec un fil conducteur pour atteindre un objectif clair (défini au début du stage selon l'avancée du projet).

Qualifications:
Etudiant universitaire (1e, 2e, 3e, Master ).

Pas de requis particulier si ce n'est que ce travail dispose d'un fil conducteur pouvant déboucher sur un TFE.

Autonome, flexible, bonne communication, esprit de synthèse, niveau d'anglais minimum pour s'adresser à tous les départements Mithra.


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