Neelam Kumar

Supervisor Quality Audits @Fresenius Kabi

Toronto, ON, CA

Conducts internal audits to ensure compliance with GMP, Vigilance, MedicalDevice Regulations, and ISO 9001/13485 standards. Performs third-party audits for suppliers, warehouses, and laboratories,ensuring compliance with GMP, CDS, Medical Devices, and Vigilance regulations. Maintains the Approved Vendor List, ensuring accuracy and currency. Manages Quality Agreements with fabricators, warehouses, wholesalers, andlaboratory services. Acts as backup liaison for communication with regulatory bodies regardingupdates/changes to DEL or MDEL requirements. Accountable for compliance with regulatory, global, and internal processes.Engages with external stakeholders, including regional and corporate qualityteams, third-party site quality personnel, and Health Canada. Oversees regulatory compliance, ensuring adherence to relevant laws,standards, and guidelines.