Quality Assurance Auditor I – Canada
6 months ago
Area of responsibility 1: [Quality Assurance].
Main activities
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 InspectionMaintain Quality Assurance files and trackersAudits, as neededAssist with deviations and investigationsChange ControlsSOP review and revisionsArchival of GMP recordsMaintain 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
Area of responsibility 2: [Performance]
Main activities
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
Area of responsibility 3: [Regulatory Compliance].
Main activities
Support customer audits ; participate, document and follow through on commitments to Health Canada Inspectorate, Veterinary Drug Directorate and other governmental inspection agencies.
Maintains 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 gGroup reduces the compliance risk to Virbac and its customers.
Area of responsibility 4: [Quality Planning]
Main activities
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 (Diploma and experience)
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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