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 positive stock returns, ensuring compliance with GMP guidelines and internal quality standards.

📌 Quality Assurance Executive (Ahmedabad)
🏢 Emcure Pharmaceuticals
📍 Ahmedabad