Quality Assurance Specialist
Cardinal Health Canada is a key player in the healthcare supply chain, providing a vast array of products to healthcare facilities. They are seeking a Quality Assurance Specialist to join their Regulatory Affairs and Quality Assurance team, focusing on executing quality programs and ensuring compliance with regulatory standards.
Responsibilities
- Ensures the fulfillment of external reporting requirements related to area of specialty, such as submitting necessary materials for product recalls. Submits reports for internal review prior to submission to regulatory bodies
- Executes internal programs to define Quality guidelines and track adherence to these guidelines. Provides guidance to internal stakeholders regarding adherence to internal Quality Assurance policies and procedures as well as external requirements
- Responds to significant quality issues and based on the direction from the Manager, creates reports on relevant quality metrics and trends and gathers relevant information from internal stakeholders
- Supports of the Change Control Program, by assessing Quality Assurance implications and impacts of operational and product changes, with a focus on specialty area
- Gathers necessary information from products and operations stakeholders and generates reports on quality metrics to assist Senior Specialists and the Manager in responding to regulatory queries, regulatory audits, and corporate
- Supports the Manager, Quality Assurance in quality audits and inspections of distribution centers within the region. Records quality issues and provides draft reports and insights to the Manager, for delivery to the Operations stakeholders
- Partners with Senior or Principal Specialist on complex regulatory submissions, operational recommendations, product analyses, and other tasks in order to develop advanced knowledge of relevant regulations and internal processes
Skills
- 0-2 years of experience
- Bachelor's degree in related field, or equivalent work experience
- Highly organized, problem solving, analytical and focused
- Proven communication skills (verbal, written and presentation skills)
- Comprehensive knowledge of the Health Canada Food and Drug Act, Canadian Medical Devices Regulations, Drug Regulations and GMP, Natural Health Product Regulations, Cosmetics and Consumer Regulations, as an asset
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