Quality Assurance Specialist
vor 1 Woche
Notre client, une entreprise pharmaceutique mondiale, recherche un Quality Assurance Associate motivé pour rejoindre son équipe et superviser les activités de qualité sur le terrain. Ce rôle consiste à garantir la conformité et à surveiller les processus de fabrication des substances pharmaceutiques et du remplissage aseptique de produits biologiques, au sein d'un environnement biotechnologique de classe mondiale.
Responsabilités clés
- Revue de documentation : Vérifier et examiner les documents de production, tels que les dossiers de lots, pour garantir leur conformité aux normes de qualité.
- Surveillance sur le terrain : Suivre les activités critiques dans la zone de production et apporter un soutien en temps réel pour résoudre les problèmes et respecter les exigences BPF.
- Inspection visuelle : Superviser et soutenir le processus manuel d’inspection visuelle.
- Conformité BPF : Collaborer avec les équipes opérationnelles pour assurer le respect des BPF et des procédures internes.
- Collaboration en équipe : Travailler avec les équipes de production pour identifier et résoudre les risques qualité, traiter les écarts et mettre en œuvre des améliorations de processus.
- Formation et accompagnement : Fournir des conseils et des formations aux équipes opérationnelles sur la gestion des événements et les processus qualité.
- Visites terrain : Effectuer des visites planifiées et non planifiées pour évaluer les processus, identifier des opportunités d’amélioration et assurer leur mise en œuvre.
- Systèmes qualité : Soutenir le déploiement et l'utilisation efficace des systèmes qualité définis par les procédures de l'entreprise.
- Amélioration continue : Participer activement à l’identification et à la mise en œuvre d’améliorations en matière de qualité et d’opérations.
Qualifications clés
- Diplôme en ingénierie, biotechnologie, pharmacie ou gestion de la qualité, ou expérience équivalente dans des environnements pharmaceutiques/biotechnologiques.
- Expérience de 3+ ans en assurance qualité opérationnelle ou production aseptique (préférée).
- Connaissance des processus d’inspection visuelle manuelle (un atout).
- Compétences interpersonnelles et communicationnelles solides, avec une capacité à former et collaborer efficacement.
- Proactivité dans l’identification des risques, la documentation des meilleures pratiques et la proposition d’améliorations.
Informations pratiques
- Mode de travail : Présence sur site requise.
- Langues : Français et/ou anglais
- Durée : 1 an (avec possibilité d’extension)
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