POSITION PROFILE Title: Associate, Quality Assurance Reports to: Assistant Manager, QA

Job Function Ensure the Quality System complies with regulatory requirements of Health Canada, USFDA, and other applicable regulatory bodies. Maintain RRCL’s quality systems and practices to meet regulatory audit expectations for all serviced markets. Support the achievement of RRCL’s Quality Goals aligned with identified market and regulatory requirements. Implement and sustain robust processes and procedures to ensure the development of high-quality pharmaceutical products compliant with regulatory standards. Collaborate with Global Quality to harmonize and continuously improve quality systems and share best practices.

Duties and Responsibilities Develop and maintain training programs for new and existing personnel. Perform Data review for HPLC and other performance test data Ensure audit trail reviews for applicable electronic systems. Support the Site Quality Head in the preparation and hosting of regulatory and internal audits. Maintain the retention sample inventory for submission batches. Review, approve, and periodically update Standard Operating Procedures (SOPs), ensuring compliance with current regulatory requirements. Manage service provider qualifications and support Corporate QA (CQA) in vendor management activities. Lead Quality Notification management: track QMS dashboards, coach laboratory personnel in technical writing, serve as SME in root cause analysis, and support CAPA implementation. Review GMP documentation from external service providers for compliance and alignment with RRCL’s Quality Management System. Stay current with best practices and regulatory expectations to provide technical input during product development. Review and approve internal documentation to ensure compliance with quality and data integrity standards. Manage equipment calibration schedules and review calibration records for all instruments and equipment. Perform other duties as assigned by the reporting manager or senior management.

Skills and Qualifications Master’s degree in chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline, or equivalent education and experience. Minimum 3 years of progressive experience in the pharmaceutical industry, with strong knowledge of the product development lifecycle. Experience in Quality Control and Quality Assurance functions within pharmaceutical manufacturing and distribution environments. Relevant experience in nasal/inhalation product development, including review and approval of scientific documentation and risk assessments. Experience in HPLC data review is preferred. Demonstrated expertise in quality assurance activities, including investigations, deviations/CAPA management, and audit hosting. Strong technical writing and SOP development skills. Proactive, results-oriented, and detail-focused professional with a positive attitude. Excellent interpersonal and collaboration skills across all organizational levels. Proven ability to work effectively under pressure and meet tight deadlines.