Quality System and Compliance

6 months ago

Montréal, Canada G Canada Therapeutics Full time

Vous souhaitez rejoindre une équipe internationale qui travaille à l'amélioration de l'avenir des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis sa fondation à Barcelone en 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nos unités opérationnelles développent, produisent et commercialisent des médicaments, des solutions et des services innovants dans plus de 100 pays et régions.

**Sommaire du poste**:
Le spécialiste, système qualité et conformité est affecté aux tâches et responsabilités au sein du département Système qualité et conformité. Elle/il fournit le soutien technique de routine dans les tâches reliées à la gestion des non-conformité (p.e. documentation, formation, conformité, planification, etc.). Peut être responsable de la coordination des assignations de travail et de la formation d’autres employés.

**Key Duties and Responsibilities**:

- Effectue la collecte de données, les révisions et peut analyser les données ;
- Effectue le maintien du dossier de gestion de la conformité (liste active des évaluations de conformité;
- Aborde et résout les problèmes conformément à la procédure écrite (c-à-d SOP, etc.) ou ç la pratique;
- Fournit et coordonne le soutien aux responsables des évaluations de conformité ;
- Fournit des conseils pour s’assurer que l’équipe de conformité effectue l’évaluation de la conformité de manière cohérente ;
- Peut former des employés ;
- Initie le processus d’évaluation de la conformité pour le secteur Qualité, documente la non-conformité ; effectue des revues périodiques, au besoin ;
- Respecte les bonnes pratiques de fabrication cGMP et les pratiques de sécurité du département ;
- Élabore des activités de réduction ou atténuation de non-conformité visant à réduire ou à éliminer la non-conformité, au besoin ;
- Dirige des équipes multidisciplinaires avec des objectifs hautement techniques. Communique les propositions de projet à la haute direction et suit le projet jusqu’à son achèvement réussi ;
- Prépare, examine et, dans certains cas, approuve les révisions des SAO, les demandes de contrôle des modifications, les entrées du système de suivi des incidents ainsi que les rapports d’enquête ;
- Les Interactions pour ce poste (à l’exception de la gestion des fournisseurs) sont essentiellement internes au site de GCT.

**Exigences du postes**:

- Diplôme universitaire (BSc/BA) de préférence dans un programme (science, technologie, ingénierie ou mathématiques) et 4 ans d’expérience connexe ou une combinaison équivalente d’éducation et d’expérience

**Position Summary**

The Quality System and Compliance Specialist is assigned duties and responsibilities within the Quality Compliance Department. She/he provides routine technical support for various tasks related to non-compliance Management (i.e., documentation, training, compliance, p scheduling, etc.). He/she may be responsible for coordinating work assignments and training of other employees.

**Key Duties and Responsibilities**
- Collects, reviews, and may analyze data.
- Maintains the compliance management file (list of living compliance assessments).
- Addresses and resolves problems according to written procedure (i.e., SOP, etc.) or practice.
- Provides and coordinates support for compliance assessments owners.
- Provides guidance to ensure that the Compliance Team conducts compliance assessment in a consistent manner.
- May train employees.
- Initiates the compliance assessment process for Quality area, documents non-compliance; performs periodic reviews, as necessary.
- Follows cGMP and department safety practices.
- Develops compliance reduction or non-compliance mitigation activities intended to reduce or eliminate compliance, as necessary.
- Leads multi-discipline project teams with highly technical objectives. Communicates project proposals to senior management and follows project through to successful completion.
- Prepares, reviews, and in some cases approves, SOP revisions, Change Control Request, Incident Tracking System entries and investigation reports.
- Interactions by this position (with the exception of supplier management) are primarily internal to the GCT site.

**Qualifications required**:

- BS/BA degree preferably in a STEM (science, technology, engineering or mathematics) curriculum and 4years of related experience or equivalent combination of education and experience.
- Excellent communication skills (written and verbal) with familiarity of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requiremens/guidelines (i.e. Eudralex, PIC/s, Health Canada, etc.).
- Bilingual (French and English preferred).

**En savoir plus à propos de Grifols**:
**Localisation**:NORTH AMERICA : Canada : Montreal**:CAQUEBEC - Qu

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