Senior Quality Assurance Associate
Responsibilities Ensure compliance with Health Canada regulations, GMP requirements, and internal quality standards.
Maintain and support continuous improvement of the Quality Management System (QMS).
Manage deviations, non-conformances, quality complaints, change controls, and CAPAs.
Review batch documentation and support product disposition activities.
Coordinate annual product quality reviews and identify quality trends and improvement opportunities.
Manage product recalls and withdrawals when required.
Oversee supplier and subcontractor quality performance and maintain quality agreements.
Participate in internal, external, and regulatory audits and inspections.
Support inspection readiness and follow-up on audit observations and corrective actions.
Provide quality guidance and training to internal teams.
Collaborate with cross-functional stakeholders to ensure ongoing compliance and operational excellence.
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