Compliant handling Vigilance reporting activities for US FDA, MIR Europe, andCanada health reports.-Evaluation of complaints based upon the events reported and databasetrending analysis.-Ensured timely completion of all Quality Assurance deliverables.-Maintained a comprehensive understanding of data requirementsfor technical and adverse event complaints, ensuring compliance withregulations and directives.-Supported Corrective and Preventive Action (CAPA).

Supported the development and updates of the Quality Management System.-Investigated Complaints for manufactured products, ensuring adherence toCE/ISO requirements.-Documented thorough investigations, maintained complaint files, and escalatedissues as necessary.-Supported CAPA management, Supplier, and Complaint management.-Collaborated with QA, manufacturing, and internal departments to determineroot causes and implement solutions.

Quality assurance of Stem cell processing unit adhering to Good manufacturingpractices throughout the process.Conducted internal quality audits, ensuring compliance with established systemsand procedures.-Monitored and maintained cGMP compliance status, aligning with regulatoryexpectations.-Adept at verifying processes and systems alignment with standard operatingprocedures (SOPs) and current regulatory expectations.-Implemented corrective and preventive actions to enhance audit observationcompliance.-Played an integral and proactive role in the training management program,ensuring adherence to quality standards in a controlled environment.