Quality Assurance Specialist
il y a 6 jours
Spécialiste Assurance Qualité
CDI
Finalité de la fonction:
Dans le cadre de la mise en place d’une usine de production biotechnologique, Just-Evotec Biologics EU est à la recherche d’un Spécialiste Assurance Qualité motivé qui souhaite participer à l’aventure Just Evotec pour améliorer l'accès mondial aux produits biothérapeutiques.
A ce titre, durant la phase de lancement du site, vous serez amené.e à:
- Revoir et approuver la documentation rédigée par nos partenaires pour les différents systèmes du site: équipements de bioproduction ou de contrôle qualité, utilités, locaux, etc. Les documents concernées peuvent être : protocoles de test, protocoles exécutés, matrices de traçabilité, rapport de validation.- Être le Représentant Qualité pour la gestion de non-conformités de qualification.
Vous aurez la charge de plusieurs systèmes en fonction de votre profil.
Après la phase projet, vous pourrez être amené.e à:
- Suivre les change control et les déviations des secteurs Facilities & Engineering et Qualification- Revoir et approuver les procédures opérationnelles- Participer à l’amélioration continue du service.- Assurer le reporting de votre périmètre auprès de votre supérieur hiérarchique
Formation / Profil:
- Vous êtes titulaire d’un bac+2/3, orienté qualité, microbiologie ou bioproduction. Vous avez idéalement une expérience opérationnelle réussie (y compris stage ou alternance) en qualification.- Vous connaissez les Bonnes Pratiques de Fabrication partie I & II, et particulièrement des annexes 1 et 15.- Une formation et/ou une expérience dans le domaine de la bioproduction est un atout.- Vous êtes volontaire, dynamique, avez de bonnes qualités relationnelles et avez l’esprit d’équipe.- Vous avez un niveau nécessaire à la compréhension orale et êtes à l’aise à l’écrit.
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Quality Assurance Specialist
Permanent position
As part of the setting up of a biotechnology production plant, Just-Evotec Biologics EU is looking for a motivated Quality Assurance Specialist who wants to be part of the Just Evotec adventure to improve global access to biotherapeutic products.
As such, during the site launch phase, you will be required to:
- Reviewing and approving the documentation drawn up by our partners for the site's various systems: bioproduction or quality control equipment, utilities, premises, etc. The documents concerned may be: test protocols, executed protocols, traceability matrices, validation reports.- Acting as Quality Representative for the management of qualification non-conformities.
You will be responsible for several systems, depending on your profile.
After the project phase, you may be required to:
- Monitor change control and deviations in the Facilities & Engineering and Qualification sectors- Review and approve operational procedures- Participate in the continuous improvement of the service.- Reporting on your area of responsibility to your line manager.
Position Requirements- You have a 2/3-year degree in quality, microbiology or bioproduction. Ideally, you will have successful operational experience in qualification.- You are familiar with Good Manufacturing Practices part I & II, and in particular appendices 1 and 15.- Training and/or experience in biomanufacturing would be an advantage.- You are self-motivated, dynamic, have good interpersonal skills and be a team player.- You have the necessary level of oral comprehension and are at ease in writing.
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