QA Shopfloor Associate

vor 1 Woche

Basel, Basel-Stadt, Schweiz Takeda Pharmaceutical Vollzeit
**À propos du poste**:
Le département Qualité de Takeda Neuchâtel est à la recherche d'un(e) **Quality Assurance on the shopfloor Associate** motivé(e) pour rejoindre l'équipe dédiée à la supervision des activités Qualité sur le terrain pour les secteurs de production de Substance pharmaceutique (**Bulk Drug Substance)** et Remplissage Aseptique (**Fill&Finish)** de produits biologiques.

Il s'agit d'une opportunité de carrière passionnante pour un(e) professionnel(le) de la qualité qui souhaite s'engager dans une culture d'équipe dans un environnement de production biotechnologique de classe mondiale.

En tant que collaborateur Assurance Qualité, vous serez directement rattaché au superviseur Assurance Qualité et serez responsable de la conformité et de la surveillance de la qualité des activités sur le terrain tout au long du processus de fabrication.

L'Associate Quality On the Shop Floor est le responsable de l'Assurance Qualité pour les activités de routine BPF (Bonnes Pratiques de Fabrication) terrain dans les secteurs de production de Substance pharmaceutique (**Bulk Drug Substance)** et Remplissage Aseptique (**Fill&Finish)** de produits biologiques. Il/Elle assurera une étroite collaboration avec les équipes sur le terrain afin d'assurer la production d'un produit de qualité tout en identifiant les améliorations et réduisant de manière préventive les risques compliances.

**Comment vous contribuerez**:

- Observer les activités critiques en zone de production et aider à la résolution de problème en temps réel. La personne assure un accompagnement continu en zone et collabore avec les équipes de production pour mettre en œuvre les actions permettant de garantir la qualité du produit.
- Soutenir la Conformité aux BPF (bonnes pratiques de fabrication) et aux procédures Takeda en définissant et maintenant le partenariat entre la Qualité et les Opérations ;
- Coacher les équipes opérationnelles dans la gestion des événements ;
- Collaborer avec les équipes terrain et apporter du support quant à la résolution des problèmes et à l'identification des causes à l'origine des déviations ;
- Participer à la définition des CAPA (actions correctives et préventives), à leur implémentation et à leur revue d'efficacité ;
- Soutenir le déploiement, l'implémentation et l'utilisation des Systèmes Qualité comme défini dans les procédures Takeda ;
- Participer aux améliorations continues en collaboration avec les équipes opérationnelles ;
- Être acteur du processus Quality On The Shopfloor;
- Revoir la documentation inhérente au processus de production en zone (ex : dossiers de lot)
- Être le référent en zone de production de toutes les questions relatives à la Qualité
- Identifier de manière préventive les potentiels risques qualité en collaboration avec la production.

**Ce que vous apportez à Takeda**:

- HES ou diplôme universitaire en Ingénierie, Biotechnologie, Pharmacie ou « Quality Management » appliqué aux procédés industriels ou expérience équivalente dans des sociétés pharmaceutiques et /ou biotechnologiques.
- Idéalement 3 années d'expérience en Assurance Qualité opérationnelle ou en Production aseptique.
- Est un partenaire mais ne se substitue pas à la Production.
- Relève, documente et partage les bonnes pratiques, les éventuelles opportunités d'améliorations voire les écarts de manière factuelle.
- Remonte les points observés lors des gouvernances.
- Est moteur dans le changement.
- Donne du sens à ses décisions.
- Transmets ses connaissances / coaching.
- A des capacités à simplifier la complexité.
- A un excellent sens de l'écoute.
- Communique de manière aisée.
- A une connaissance parfaite de la langue française.
- A une utilisation fluide du pack office.

**Ce que Takeda vous offre**:

- Salaires compétitifs.
- Couverture complète des accidents.
- Participation aux primes d'assurance maladie.
- Plans de retraite avantageux.
- Repas subventionnés.
- Participation financière aux activités sportives de ses employés.
- Transport : soutien aux abonnements du transport public local, parking gratuit, progra.
- Takeda Neuchâtel offre à ses collaborateurs un cadre et des conditions de travail attract sécurité, le développement et l'évolution de carrière de ses collaborateurs sont au cœur nos politiques Ressources Humaines, Santé, Environnement et Sécurité.
- Takeda Neuchâtel est un employeur engagé envers ses collaborateurs et les générations.

**En savoir plus sur Takeda Neuchâtel**:

- Takeda Neuchâtel est certifiée Entreprise Formatrice par le Secrétariat d'Etat à l'Economie Suisse. N apprentis dans divers domaines tels que le contrôle qualité en laboratoire, la logistique, l'informatiqu biopharmaceutique._

**_ "Empowering our people to shine" :_**:
**Locations**:
CHE - Neuchatel

**Worker Type**:
Employee

**Worker Sub-Type**:
Regula

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