Quality Assurance Manager

il y a 2 semaines


Bruxelles, Région de Bruxelles, Belgique Nuwhï Temps plein
Le Pharmacien Responsable (QP) propose et met en place des actions permettant de garantir la qualité des fabrications et le service rendu aux clients. Il est le garant du respect des bonnes pratiques de fabrication et de distribution, et veille au bon fonctionnement de l'établissement. Il libère les lots de matières premières et de produits finis réceptionnés ainsi que les préparations réalisées sur le site

**Tâches et Responsabilités**:
1) ASSURANCE QUALITE**:

- élaborer et actualiser le Manuel d'Assurance Qualité de l'entreprise,
- définir les objectifs qualité de l'entreprise,
- définir et appliquer la politique de qualité vis-à-vis des fournisseurs et sous-traitants ;
- établir le bilan annuel de qualité des produits (incidents, déviations, non conformités, anomalies, réclamations,...), évaluer l'adéquation des actions correctives et analyser les tendances,
- proposer des améliorations et des évolutions dans le domaine de la qualité ;
- enregistrer et formaliser les changements (spécifications, tests, processus, équipements,...).

2) AFFAIRES PHARMACEUTIQUES:

- enregistrer, traiter et gérer, selon les procédures en vigueur, les réclamations internes et externes relatives à la qualité des produits fabriqués, sous-traités ou achetés ;
- fournir un support dans le cadre des réponses adressées à l'AFMPS concernant les écarts relevées lors des inspections;
- assurer une veille pour tout ce qui concerne la Qualité.

3) DOCUMENTATION QUALITE:

- approuver l'ensemble de la documentation qualité (procédures, modes opératoires et documents)
- rédiger ou coordonner la rédaction et actualiser les procédures générales applicables à l'ensemble des sites ;
- coordonner la rédaction des cahiers des charges de sous-traitance ;
- superviser l'organisation de la gestion documentaire qualité.

4) AUDITS:

- définir le programme et le périmètre des audits internes et externes (fournisseurs et sous-traitants) ;
- élaborer et valider le calendrier annuel des audits ;
- valider le canevas des audits internes et externes ;
- contribuer à leur réalisation ;
- participer à l'évaluation.

**Profil recherché**

Diplôme de pharmacien d'industrie

Certification QP

Expérience dans le domaine de la qualité

Connaissance des GMP et GMP

Type d'emploi : Temps plein, CDI

Salaire : à partir de 4.500,00€ par mois

Avantages:

- Assurance hospitalisation
- Chèques repas
- Éco-chèques
- Voiture de société

Flexible Language Requirement:

- Néerlandais non requis

Programmation:

- Travail de jour

Lieu du poste : En présentiel
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