Quality Assurance Auditor I – Canada

噩牢慣; Cambridge; On-site; CAD 60,000 - 80,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Quality Assurance Auditor in Cambridge, Canada. This role involves overseeing product quality, ensuring compliance with regulatory standards, and collaborating with third-party manufacturers. The successful candidate will need a strong background in quality assurance practices and effective teamwork skills to enhance operational performance.

Qualifications

• Must hold a Canadian University degree or equivalent.
• Minimum 2-3 years of experience in pharmaceutical manufacturing/distribution.

Responsibilities

• Perform final release of product for distribution in Canada.
• Support customer audits and maintain appropriate Health Canada records.
• Propose improvement actions and report on performance.

Skills

Critical thinking

Collaboration

Analytical skills

Attention to detail

Education

University degree in a science related field

Job description

Within the framework of Virbac's global Quality standards, this position supports products manufactured and / or distributed in the Canadian market, continuously improving key systems and processes to ensure product quality, regulatory compliance and efficiency. This position works directly with Third Party Manufacturers, warehouse facilities as well as various Virbac Corporate departments.

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

Critical thinking

Ability to collaborate with others

Strong analytical skills

Attention to detail and accuracy

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Quality Assurance Auditor • Cambridge, Canada