Quality Assurance Associate

3 weeks ago


Kirkland, Canada Accord Healthcare Canada Full time

This is18month full time contract position in Quality Assurance department at Accord Healthcare in Montreal which requires,1-3 years working experience in Quality Assurance area of Canadian Pharmaceutical CompanyAwareness of Canadian GMP requirements as per Health Canada guidanceKnowledge of Health Canada's compliance requirements for an importer/distributor of drug products including establishment license, API (Active Pharmaceutical Ingredient) GMPs and recall proceduresKnowledge of Product release process and Product life cycle management in Canadian market from Quality perspectiveMaintenance of Quality Management System (QMS) including company's Change controls (CC), Corrective Action Preventive Action plan (CAPA), Deviations, Out of Specifications (OOS) investigations, Complaints and Annual Product Quality Reviews (APQRs)Active participation in Health Canada GMP and Compliance auditsChange control evaluation for the product release processEnsure product compliance to the most currently approved dossier which includes Product release specifications, Master manufacturing and packaging batch records, Process and Packaging validation reports and assessment of any deviationsMaintenance of technical staff training dossiers and SOPs (Standard Operating Procedures)Dynamic and team player



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