Operational Quality Coordinator

il y a 1 semaine


Lessines, Wallonie, Belgique BAXTER Temps plein
**This is where you save and sustain lives**

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives—where your purpose accelerates our mission.

**LE JOB**

Le rôle de l'Operational Quality Coordinator est d'assurer la conformité des processus de fabrication aux requis qualité et aux Bonnes Pratiques de Fabrication.

Ce rôle a également comme objectif de contribuer à l'amélioration continue des processus qualité au sein de l'environnement de production.

**TACHES GENERALES**
- Gérer, coordonner et contrôler les activités des départements Sterile Drugs afin de s'assurer que les produits fabriqués répondent aux exigences et aux attentes des clients
- S'assurer que les GMP et les autres exigences sont respectées dans le domaine de responsabilité (département SD)
- Examiner et enquêter sur les évènements et les non-conformités liés au processus de fabrication
- Assurer une enquête approfondie sur les non-conformités et les plaintes et identifier les améliorations qui permettront d'éliminer le défaut (CAPA)
- Propriétaire de non-conformités et CAPA
- Assurer la documentation et la fermeture en temps utile des dossiers de non-conformités et des CAPA
- Gérer les activités de réinspections (identification, initiation et révision)
- S'assurer que les procédures et spécifications dans son domaine de contrôle sont à jour
- Examiner et approuver les modifications de la documentation
- Examiner et évaluer les demandes de contrôle des changements de processus
- Réaliser des rapports sur les indicateurs clés de performance, le cas échant
- Effectuer régulièrement des visites de qualité GEMBA (enquête, inspection, réunion de niveau )
- Le cas échéant, faire remonter l'information pour les problèmes de qualité aux Superviseur/Manager PQ
- Participer à l'exécution et à la coordination des projets et initiatives d'amélioration de la qualité
- Participe aux inspections réglementaires (audits internes/locaux et externes)
- Participe à l'implémentation EMS / 6S et à l'amélioration continue

**PROFIL RECHERCHE**
- Vous détenez un Master et/ou 3 ans d'expérience professionnelle dans un domaine opérationnel, la qualité ou l'engineering, de préférence dans le secteur de la santé.
- Vous disposez d'une expérience dans le milieu manufacturing et environnement GMP
- Approche concrète et pragmatique
- Esprit critique et orienté solution
- Esprit d'analyse et de synthèse
- Sens de la collaboration et du travail en équipe.
- Capable de travailler en autonomie et d'une façon rigoureuse.
- Aptitude rédactionnelle et sens de la communication.
- Bon niveau d'anglais
- Maitrise des outils de bureautique (word, excel)
- Une qualification 'Six Sigma Green Belt' est un plus.
- Une connaissance de TrackWise 8 est un plus

**Reasonable Accommodations**

**Recruitment Fraud Notice**

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.

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