- 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
Core Competencies
Demonstrates expertise in managing Change Control and CAPA systems while ensuring compliance with cGMP and regulatory requirements. Proficient in conducting quality risk assessments, training employees, and maintaining documentation management systems.
Highest-signal resume keywords
- Change Control Management
- CAPA Systems Management
- Quality Risk Assessment
- Regulatory Compliance
- SOP Development
ATS Optimization Keywords
Hard Skills
- Quality Risk Assessment
- Change Control Management
- CAPA Systems
- SOP Development
- Data Analysis
- Compliance Management
- Quality Deviation Investigation
- Documentation Management
- CGMP Compliance
- Regulatory Guidelines Familiarity
Soft Skills
- Excellent Communication Skills
- Problem Solving
- Training and Coordination
Industry Keywords
- CGMP
- FDA
- Eudralex
- PIC/s
- Health Canada
Tools & Technologies
- Documentation Management System
📌 Specialist, Quality System and Compliance (Montreal)
🏢 Jobtailor
📍 Montreal
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