Quality compliance training specialist developing GXP and technical training programs for Grifols, a global healthcare company. Supporting pharmaceutical manufacturing, quality, validation and environmental safety objectives.
About the role
- Quality compliance specialist managing CAPA, risk assessments, SOPs, and cGMP systems. Supporting Grifols’ global plasma-derived medicines and transfusion healthcare operations.
Responsibilities
- Manage Change Control and CAPA systems
- Perform assigned tasks related to quality risk assessments
- Support the risk team and help ensure consistent risk assessment practices
- Review and approve risk reports as required
- Prepare, review, and sometimes approve SOP revisions in the Documentation Management System
- Participate in quality deviation investigations
- Collect, review, and potentially analyze data
- Maintain compliance management files
- Address and resolve problems according to written procedures and SOPs
- Provide and coordinate support for compliance assessment owners
- Train employees as needed
- Initiate compliance assessments for the Quality area and document non-compliance
- Conduct periodic compliance reviews as necessary
- Follow cGMP and departmental safety practices
- Develop activities to reduce or mitigate non-compliance
- Coordinate work assignments and training of other employees as needed
- Report to the Quality System and Compliance Manager
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 written and verbal communication skills
- Familiarity with domestic and applicable foreign regulatory agency requirements/guidelines, including Food and Drug Administration, Eudralex, PIC/s, and Health Canada
- English proficiency required for document exchanges and communications with Grifols sites outside Quebec and Canada
- Bilingualism in French and English preferred
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