Senior Quality Assurance Specialist - Consultant
Cencora
Senior Quality Assurance Specialist supporting Cencora's pharma commercialization services in Canada. The role involves managing establishment licenses, releasing commercial products and clinical trial supplies, reviewing quality documentation, and coordinating with clients and foreign manufacturing sites to ensure compliance with Health Canada regulations.
Responsibilities
- Maintain importer Drug Establishment Licenses and manage foreign site approval processes for multiple clients
- Release commercial drug products and clinical trial supplies to the Canadian market
- Review and assess manufacturing records, Certificates of Analysis, and product release documentation
- Process deviation investigations, product quality complaints, and change control requests with trend analysis
- Support audits, inspections, and recall events; assist with QA policy development and implementation
Requirements
- Bachelor's degree in pharmaceutical or healthcare-related field
- Minimum 5 years' Quality Assurance experience
- Comprehensive knowledge of Food and Drugs Act and Health Canada GMP regulations
- Demonstrated ability to manage complex quality documentation and compliance processes
- Regulatory Affairs or Quality Assurance certification preferred
- Experience conducting vendor audits preferred
Vacancy posted 2 days ago
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