Quality System and Compliance Associate-associé

7 months ago

Montréal, Canada G Canada Therapeutics Full time

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

**Position Title: Quality System and Compliance Associate**

**Reports to: Quality System and Compliance Supervisor**

**Position Summary**:
The Quality System and Compliance Associate is an entry level position and provides routine technical support for various tasks related to the Documentum Compliance Manager (DCM) or any new implemented documentation system at Grifols Canada Therapeutics Inc in order to meet quality goals.

**Key Duties and Responsibilities**
- Collects, reviews, and may analyze data.
- Coordinates with users in their respective departmental procedures to begin document workflow lifecycles in DCM.
- Makes decisions within a well-defined area.
- Coordinates with person responsible for Training Program to update the Grifols Training Platform for all departments when new procedures are approved.
- Addresses and resolves problems according to written procedure (i.e., SOP, etc.) or practice.
- Makes sure that the archiving system is maintained and meets quality standards.
- Coordinates will all departments (Validation, Quality Control, Production ) that all the raw data and reports generated are properly archived.
- Communicates effectively and promptly at all levels of the organization, supporting department objectives and management decisions.
- Demonstrates high levels of values integrity.
- Follows cGMP and department safety practices.
- May perform other duties such as document author/review, change control, discrepancy management, track quality metrics.

**Qualifications required**:

- College Diploma (DEC) or equivalent. Associate’s degree in science preferable.
- Minimum 2 years’ industry experience within Health Canada and/or FDA regulated and biopharmaceutical or devices environment preferred.
- Ability to read documents for extended periods.
- Excellent communication skills (written and verbal).
- Bilingual (French and English preferred).

**Titre du poste : Associé, système qualité et conformité**

**Relève du : Superviseur, système qualité et conformité**

**Sommaire du poste**:
L’associé au système qualité et à la conformité est un poste de niveau d’entrée qui fournit un soutien technique de routine pour diverses tâches liées au système de conformité Documentum (DCM) ou à tout autre nouveau système de documentation mis en place chez Grifols Canada Thérapeutiques Inc afin d’atteindre des objectifs de qualité.

**Key Duties and Responsibilities**
- Effectue la collecte de données, révise et peut analyser des données ;
- Coordonne avec les utilisateurs des différents départements pour commencer le flux du cycle de vie des documents dans DCM ;
- Prend des décisions dans un domaine bien défini ;
- Coordonne avec la personne responsable du programme de formation pour mettre-è-jour la plateforme de formation Grifols pour tous les départements lorsque de nouvelles procédures sont approuvées ;
- Aborde et résout les problèmes conformément à la procédure écrite (c.à-d. SOP, etc) ou à la pratique ;
- S’assure que le système d’archivage est maintenu et répond aux normes de qualité ;
- Coordonne avec tous les départements (Validation, Contrôle Qualité, Production ) afin que toutes les données brutes et les rapports générés soient correctement archivés ;
- Communique efficacement et rapidement à tous les niveaux de l’organisation, en soutien aux objectifs départementaux et les décisions de gestion ;
- Démontre de hauts niveaux d’intégrité et de valeurs ;
- Respecte les bonnes pratiques de fabrication et les pratiques de sécurité du département ;
- Peut effectuer d’autres tâches telle que rédaction/révision de documents, contrôle des changement, la gestion des écarts, le suivi des mesures de qualité.

**Exigences du postes**:

- Études : DEC ou équivalent. Diplôme d’associé en sciences souhaitable ;
- Minimum 2 ans d’expérience dans l’industrie au sein de Santé Canada et/ou de la FDA réglementé et biopharmaceutique ou dispositifs environnement préféré ;
- Capacité de lire des documents pendant de longues périodes ;
- Excellentes compétences en communication (écrite et verbale) ;
- Bilinguisme français et anglais préféré.

**Location**:NORTH AMERICA : Canada : Montreal**:CAQUEBEC - Quebec**

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