Vrishti Thakur

Manage and maintain Quality Management System (QMS) documentation in compliance with regulatory requirements and internal SOPs Initiate, investigate, and track deviations, incidents, and non-conformances, ensuring timely closure and proper documentation Perform impact assessments for quality events (e.g., temperature excursions, documentation errors) to evaluate product safety and compliance Review and approve quality records, including logs, reports, and forms, ensuring accuracy and completeness Support CAPA (Corrective and Preventive Actions) activities, including root cause analysis and effectiveness checks Ensure compliance with Health Canada, GMP (Good Manufacturing Practices), and internal quality policies Assist in audits and inspections, including preparation of documentation and responding to audit observations Monitor and trend quality data to identify recurring issues and support continuous improvement initiatives Conducts required training activities for Center Notifications, Corporate Directives, SOP changes, and initial SOP implementations.