Specialist Quality Assurance (Technical Quality)
About this role
Specialist Quality Assurance (Technical Quality)
To provide Technical Quality oversight (Validation, Engineering Controls, Maintenance and Calibration) for Sun Canada’s manufacturing facilities, utilities, equipment, laboratories and processes. This role collaborates cross-functionally with system owners and their supporting technical teams (e.g. process development, engineering, validation, maintenance, metrology) to provide regulatory guidance and implement procedures and standards that ensure sustained compliance with Sun policies and GMPs (US FDA, 21CFR part 11, Health Canada, GAMP). This includes evaluation and approval of validation, engineering and change control documentation pertaining to the following technical operations areas: Equipment/Facilities/Utilities Qualification Manufacturing Process & Cleaning Validation Maintenance/Calibration programs
Duties and responsibilities
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