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.
Pay: $50,000.00-$60,000.00 per year
Work Location: In person
