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
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