Specialist, Quality Assurance (System)- KCN Quâng Minh, Mê Linh HN

- Taking responsibility for product quality as GSP, GDP standards, current SOPs, related regulations, and client requirements
- Monitoring, collecting, and reporting safety information related to product to Drug Administrative of Vietnam as Law and simultaneously report to manufacturer as requirement
- Oversight the storage and distribution activity to ensure in compliance with the GSP/GSP requirement
- Participate in the GxP authority inspection, external audit organization (e.g. ISO) and client audits
- Plan and participate in internal audits annually; follow up all CAPAs after the audit
- Establish training matrix, annual training plan, monitor the training execution and achirve training records at Quality Assurance department
- Organize training courses on GxP standards, SOPs/ WIs, Pharmaceutical law and supplier’s requirements when necessary
- Main contact point with client related to quality topics (e.g. audit, QAA)
- Manage and monitor the implementation of corrective and preventive actions in departments
- Maintain and update the pharmacovigilance system to comply with local regulations and Client’s requirements
- Change control management related to product quality in the product life cycle supply chain
- Receive, collect, process, report adverse event and update safety information according to local regulations and contracts with partners