Project Quality Assurance Manager

Il y a 6 mois

Toulouse, France Just Evotec Biologics EU Temps plein

Intitulé du poste : Responsable Assurance Qualité Projets

Just-Evotec Biologics recherche son Responsable Assurance Qualité Projets (F/H/D). 

Finalité de la fonction : 

Dans le cadre du groupe Qualité Ingénierie et Validation (QEV) garantissez l’application des Bonnes Pratiques de Fabrication aux projets d’ingénierie et de Travaux neufs. 

Durant la phase projet, vous serez amené.e. à :

Piloter le processus d’assurance qualité pour les projets de travaux neufs et de mise à niveau de l’existant, incluant notamment les équipements de production ou d’analyse.Vous organisez la revue et l’approbation de la documentation de qualification et de validation de votre secteur en accord avec les BPF Parties I et II ainsi que les annexes 1, 2, 11 et 15.Vous réalisez vous-même des opérations de revue et d’approbation de documents, la levée des non-conformités et la libération des systèmes.

L’équipe dédiée à cette activité est composée de vous-même, d’un Spécialiste AQ ainsi que d’un technicien AQ.

Participer activement à la transition vers un mode « routine » Être l’interlocuteur privilégié des services techniques et de l’IT dans l’investigation des anomalies, la mise en place des CAPA et le support des Change Control.

Vous aurez également la responsabilité de :

Rédiger et tenir à jour les procédures et veiller aux évolutions de la règlementation de votre périmètre. Mettre en place et exploiter les outils de suivi de la performance qualité de votre périmètre et les remontées vers les revues de direction en lien avec le responsable des systèmes qualité. Assurer le reporting de votre périmètre auprès de votre supérieur hiérarchique

Vous serez amené.e à représenter votre périmètre au cours des audits clients et inspections d’autorités et à participer à l’organisation de ces derniers.

Qualifications :

Vous êtes titulaire d’un bac+5 avec une spécialisation en assurance qualité dans le domaine pharmaceutique ou Pharmacien diplômé.e, avec une expérience opérationnelle réussie d’au moins 3 ans au sein d’un établissement pharmaceutique fabricant.

Vous disposez d’une solide connaissance des 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 ainsi qu’une sensibilité à la data integrity.

Vous êtes reconnu(e) pour vos qualités relationnelles, d’écoute et pour votre esprit d’équipe, vous aimez le défi et vous aventurer sur des sujets non encore explorés.

Vous disposez de très bonnes capacités d’analyse, d’organisation et de synthèse, vous avez un forte capacité d’adaptation et êtes autonome.

Vous avez un niveau d’anglais courant aussi bien à l’écrit qu’à l’oral.

Job title: Project Quality Assurance Manager

Just-Evotec Biologics is seeking a highly motivated Project Quality Assurance Manager (F/M/D). 

Job Purpose:

As part of the Quality Engineering and Validation (QEV) group, you guarantee the application of Good Manufacturing Practices to engineering and new works projects.

During the project phase, you will be required to:

Manage the quality assurance process for new-build projects and upgrades to existing equipment, including production or analysis equipment. You will organize the review and approval of your sector's qualification and validation documentation in an environment compliant with GMP Parts I and II, as well as appendices 1,2, 11 and 15.You will perform document review and approval, non-conformance resolution and system release.

The team dedicated to this activity is composed of yourself, a QA Specialist and a QA Technician.

Actively participate in the transition to a routine mode Be the main contact for Technical Services and IT in the investigation of anomalies, the implementation of CAPA and the support of Change Control.

You will also be responsible for:

Write and update procedures and monitor changes in the regulations of your area. Set up and use quality performance monitoring tools for your scope and feedback to management reviews in conjunction with the quality systems manager; Ensure the reporting of your scope to your line manager

You will be required to represent your scope during customer audits and authority inspections and to participate in the organization of these.

Qualifications: 

You hold a Master’s degree with a specialization in quality assurance in the pharmaceutical field or a graduate pharmacist, with a successful operational experience of at least 3 years within a pharmaceutical manufacturing establishment.

You have a solid knowledge of Good Manufacturing Practices Part I & II, and particularly of Annexes 1 and 15.

Training and/or experience in the field of bioproduction, as well as a strong sensibility to data integrity are assets. 

You are recognized for your relational and listening skills and for your team spirit, you like the challenge and venture on subjects not yet explored. You have very good analytical, organizational and synthesis skills, you have a strong ability to adapt and are autonomous. 

You have a fluent level of French both written and spoken.

FR : Dans le cadre de sa politique Diversité, Evotec étudie, à compétences égales, toutes les candidatures dont celles des personnes en situation de handicap.

ENG : In the frame of our Diversity policy, Evotec considers, with equal competences, all applications including people with disabilities.

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