Quality Assurance Auditor I

1 month ago

Cambridge, Ontario, Canada Virbac Full time
Quality Assurance Auditor I - Canada

Within the framework of Virbac's global Quality standards, this position supports products manufactured and/or distributed in the Canadian market, ensuring product quality, regulatory compliance, and efficiency. This role works directly with Third Party Manufacturers, warehouse facilities, and various Virbac Corporate departments.

Main Responsibilities:

  • Perform final release of Product intended for distribution in Canada under the supervision of the Canadian Head of Quality
  • Perform Quality Assurance activities relating to Third Party Manufacturing / Warehousing:
    • AQL Inspection
    • Maintain Quality Assurance files and trackers
    • Audits, as needed
    • Assist with deviations and investigations
    • Change Controls
    • SOP review and revisions
    • Archival of GMP records
    • Maintain Finished Product Specifications
  • Expected results: Quality Standards are met for material released in the Canadian Market and transactions are processed in a timely manner. All supplier qualification activities satisfy all regulatory requirements and audit reviews
  • Main Activities for Performance:
    • Propose improvement actions and report regularly on implementation progress
    • Track third party performance and report regularly to local and corporate departments
    • Focus on standardizing all operations in the interest of improving the operating compliance and performance standards
  • Expected results: The Quality Assurance group contributes effectively to the goals of Virbac Canada
  • Main Activities for Regulatory Compliance:
    • Support customer audits; participate, document and follow through on commitments to Health Canada Inspectorate, Veterinary Drug Directorate and other governmental inspection agencies
    • Maintain appropriate Health Canada and GMP records for HC Inspectorate
    • Maintain a current knowledge of applicable governmental regulations and their application to similar industries
    • Provide required documentation to support regulatory body requests (incomplete letters, review questions and investigation progress)
  • Expected results: The Quality Assurance group reduces the compliance risk to Virbac and its customers
  • Main Activities for Quality Planning:
    • Identifies and presents evidence of quality and compliance risks to QA Management and General Manager of Canada as they appear
    • Expected results: The Quality Assurance group strategically plans resources for continuous improvement in compliance

Requirements:

  • Must hold a Canadian University degree, or a degree recognized as equivalent by Canadian accreditation body, in a science related field
  • Minimum or 2-3 years of experience in pharmaceutical manufacturing/distribution environment
  • Skills:
    • Excellent communication
    • Critical thinking
    • Ability to collaborate with others
    • Strong analytical skills
    • Attention to detail and accuracy

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