Quality Assurance Manager with Pharmacy Practices Certificate (PPC)Công Ty TNHH Novo Nordisk Việt Nam

Quality Assurance Manager (with PPC - Pharmacy Practices Certificate)
Location : Ho Chi Minh
Job scope :
• Perform the relevant tasks required by local regulation for Drug importer. Approving of receiving and dispatch of products. Inspect, review, approval or reject the product arrival company's warehouse. To maintain all necessary licenses for the affiliate to operate the business regarding quality operation perspective.
• Quality assurance including management of warehouse and distributors. Accountable for the oversight and execution of Quality Management System (QMS) to manage and maintain the quality activities in the warehouse, and ensure the safety, quality and benefit of the products that were received, picked, packed, stored, inspected, relabeled, and delivered to distributors. Executing and managing the daily quality activities at the company's pharmaceutical warehouse and be the point of contact on warehouse quality related matters. Process validation and requalification as per internal and external requirements regarding facilities, utilities, equipment, transport method. Prepare and review monthly Quality Assurance reports as well as reviews and approves documentation and records regulated by GxP (Good x Practice) requirements.
• Quality management; Ensure that the quality management system is maintained and in compliance with internal and external requirements. Identify significant quality issues and report per procedure, prioritize for action, and involve in improvement opportunities and problem solvent. Quality management review (QMR). Quality Management System (QMS) training. Handling of Finished Products for Novo Nordisk owned products. Change Control. Repackaging Marketed Product. Sample handling. Audits & inspections. Qualification and Validation of Cold Storage Facilities. Deviation Handling. Quality document control and administration/record management. Handling technical compliant.
• Key stakeholder management (internal/external); Communication of processes and procedures to related parties. Proactively engages with stakeholders in all levels to ensure their alignments.