Quality Assurance Supervisor

3 weeks ago

Montréal, Canada G Canada Therapeutics Full time

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

**Position Title: Quality Assurance Supervisor**

**Reports to: Senior Quality Director**

**Position Summary**:
**Key Duties and Responsibilities**
- Supervise all aspects of a Quality Assurance Operations business unit (documentation, laboratory operations, employee relations, etc.).
- Provide guidance as well as consult with manufacturing and internal regulatory departments on GXP matters.
- Use expertise and sound judgment to make independent decisions within defined areas of responsibility.
- Plan and analyze workflow, delegate, and prioritize, to ensure that assignments and projects are completed in a timely manner and within projected budget.
- Evaluate and assess change controls to determine applicable requirements and assist in determining regulatory reporting classification and requirements.
- Participate in regulatory and internal inspections/audits including direct discussions with auditors and providing written responses as applicable for area of responsibility.
- Supervise and Provide guidance and scientific/technical advice regarding validations and validation deviations and all deviations related to operations (Manufacturing and Quality control).
- Review and approve technical protocols and reports including stability, characterization, and validation studies.
- Review and revise Standard Operating Procedures and generate reports.
- Investigate and initiate corrective action places for quality related issues.
- Maintain current knowledge of Health Canada, FDA, EU and other regulatory agencies and industry standards.
- Communicate with cross functional departments and support groups to improve departmental performance and efficiency.
- Provide support, direction and coaching to subordinate employees in the areas of the Quality Assurance department.
- Communicate effectively and promptly at all levels of the organization.

May perform investigations and write reports. Author SOPs and other laboratory documents. Collaborate with production and PQM on projects, incident investigations, and annual product reviews. Prepare, review, and/or approve validation and/or engineering documents.

**Titre du poste : Superviseur de l’assurance de la qualitéRelève de : Directeur principal de la qualité**

**Résumé du poste**:
Le superviseur est responsable du développement et de la supervision directe de l.

**Principales tâches et responsabilités**
- Supervise tous les aspects d’une unité opérationnelle des opérations d’assurance de la qualité (documentation, opérations de laboratoire, relations avec les employés, etc.) ;
- Fournit des conseils ainsi que des consultations avec les services de fabrication et de réglementation interne sur les questions GXP ;
- Fait appel à son expertise et à son bon jugement pour prendre des décisions indépendantes dans des domaines de responsabilité définis ;
- Planifie et analyse le flux de travail, délègue et établit les priorités, pour s’assurer que les affectations et les projets sont achevés en temps opportun et dans les limites du budget prévu ;
- Évalue et estime les contrôles de changements pour déterminer les exigences qui s’appliquent et aider à déterminer la classification et les exigences réglementaires en termes de rapports ;
- Participe aux inspections réglementaires/audits internes, y compris les discussions directes avec les auditeurs et fournit des réponses écrites, le cas échéant, selon le champ de responsabilité ;
- Supervise et fournit des conseils et des conseils scientifiques et techniques concernant les validations, les écarts de validation et tous les écarts liés aux opérations (fabrication et contrôle qualité) ;
- Examine et approuve les protocoles et les rapports techniques, y compris les études de stabilité, de caractérisation et de validation ;
- Examine et révise les procédures opérationnelles normalisées et produit des rapports connexes ;
- Enquête et initie des actions correctives pour les problèmes liés à la qualité ;
- Maintient une connaissance à jour de Santé Canada, de la FDA, de l’UE et autres organismes de réglementation et des normes de l’industrie ;
- Communique avec les départements interfonctionnels et les groupes de soutien pour améliorer les performances et l’efficacité du département ;
- Fournit un soutien, une orientation et un encadrement aux employés subalternes dans les domaines du service d’assurance de la qualité ;
- Communique efficacement et rapide

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