Spécialiste, système qualité et conformité - Quality System and Compliance Specialist

GRIFOLS, S.A.•Montreal, QC

1d•Onsite

About The Position

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, p scheduling, etc.). He/she may be responsible for coordinating work assignments and training of other employees. 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.

Requirements

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.
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.).
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)

Responsibilities

Manages Change Control and CAPA systems.
Performs assigned tasks related to risk assessments. Supports risk team by providing guidance to ensure risk assessments are conducted in a consistent manner. Reviews and approves risk reports as required.
Prepares, reviews, and in some cases approves, SOP revisions in Documentation Management System.
May participate in investigation of quality deviations.
Collects, reviews, and may analyze data.
Maintains the compliance management files.
Addresses and resolves problems according to written procedure (i.e., SOP, etc.).
Provides and coordinates support for compliance assessments owners.
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 non-compliance, as necessary.
Interactions by this position (with the exception of supplier management) are primarily internal to the GCT site.