Quality Assurance Executive - Canada Market

Department: Quality Assurance - Canada
Designation: Executive / Officer - Batch Release / QMS
Qualification: M.Pharm / M. Sc
Experience: 03 to 08 years
Job Location: Ahmedabad
Job Details mentioned below:
Review and approve of all release-related documents (i.e., COAs, COMs etc.) to ensure compliance with GMP and internal quality standards.
Perform timely product release based on complete, accurate, and compliant documentation.
Facilitate compliance with Health Canada requirements, ensuringproduct release activities are aligned with regulatory expectations.
Review and assess deviations, customer complaints, investigations, and CAPAs to ensure completeness, accuracy, and appropriate quality conclusions.
Track, manage,and document changecontrols and deviations related to products,processes, suppliers, or documentation updates.
Review Annual Product Quality Reviews (APQRs) and Annual Batch Reviews to support ongoing product suitability and regulatory compliance.
Liaise with suppliers and CMOs to obtain requireddocuments such as COAs and manufacturing records
Review elemental impurity risk assessment (EIRA), Nitrosamine impurity risk assessment (NIRA), and other nitrosamine test results for finished productsto ensure compliance with Health Canadaand ICH limits.
Perform quality assessments and assign final disposition for returned drug products and good stock returns, ensuring compliance with GMP guidelines and internal quality standards.

Work arrangement
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