Mid-Level
Spécialiste, système qualité et conformité - Quality System and Compliance Specialist
Spécialiste, système qualité et conformité - Quality System and Compliance Specialist
Location: Montreal, CA
Contract Type: Regular Full-Time
Area: TECHNICAL
Req Id: 543646
Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.
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 Specialist (SAP)
Reports to: Quality System and Compliance Manager
Position Summary:
The Quality System and Compliance Specialist is responsible for day-to-day operations and projects pertaining to the creation, maintenance and documentation of Global Material and Master Data in the ERP system (SAP) for Grifols CanadaTherapeutics Inc. He/she collaborates with the Information Technology team and SAP system design users to ensure system developments encompass master data requirements without presenting adverse affects to the business. The Quality System and Compliance Specialist is assigned duties and responsibilities within the Quality System and Compliance Department. She/he provides routine technical support for various tasks related to non-compliance management (i.e., documentation, training, compliance, scheduling, etc.). He/she may be responsible for coordinating work assignments and training of other employees.
Key Duties and Responsibilities
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Create and maintain material and vendor master data, which includes, but is not limited to, material master, bills of materials/recipes, batch characteristics, inspection plans, packaging instructions.
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Maintain tables to enable accurate system functionality relating to release strategy for Finish Product.
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Performs assign tasks within Change Control and CAPA systems.
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May performs assigned tasks related to risk assessments.
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Prepares, reviews, and in some cases approves, SOP revisions in Documentation Management System.
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May participate in investigation of quality deviations.
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Collects, reviews, and may analyze data.
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Maintains the compliance management files.
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Addresses and resolves problems according to written procedure (i.e., SOP, etc.).
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Provides and coordinates support for compliance assessments owners.
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May train employees.
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Initiates the compliance assessment process for Quality area, documents non-compliance; performs periodic reviews, as necessary.
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Follows cGMP and department safety practices.
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Develops compliance reduction or non-compliance mitigation activities intended to reduce or eliminate non-compliance, as necessary.
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Interactions by this position (with the exception of supplier management) are primarily internal to the GCT site.
Qualifications required:
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BS/BA degree preferably in a STEM (science, technology, engineering or mathematics) curriculum and 4 years of related experience or equivalent combination of education and experience.
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Excellent communication skills (written and verbal) with familiarity of domestic (i.e. Food and Drug Administration) and applicable foreign regulatory agency requirements/guidelines (i.e. Eudralex, PIC/s, Health Canada, etc.).
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Bilingualism in French and English preferred (la maîtrise de l’anglais est requise pour assurer les échanges de documentations et communications avec d’autres sites de Grifols hors Québec et hors Canada (Espagne, USA))
Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec
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