Operational Quality Coordinator
Overview
This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.
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Support for Parents
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Continuing Education/ Professional Development
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Employee Heath & Well-Being Benefits
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Paid Time Off
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2 Days a Year to Volunteer
Success Profile
What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.
- Detail Oriented
- Continuous Learner
- Courageous
- Collaborative
- Critical Thinker
- Influential
Operational Quality Coordinator
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.
RESUME DE LA FONCTION
Le rôle d'Operational Quality (OQ) 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 (SD) 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 OQ
- 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 Bachelier 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.
- Notion d’anglais
- Maitrise des outils de bureautique (word, excel)
- Une connaissance de TrackWise 8 est un plus
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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.
Address
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Join Our Talent Community
We're grateful for your interest in a career with Baxter, and would like to get to know you. Joining our Talent Community is a great way to stay connected, learn more about Baxter, and help our recruiters find you if there's an opportunity that aligns with your background, skills and interests.