Title:  Manager, Quality Assurance

Job Summary

Develop and implement the global quality assurance strategy, policies, procedures and activities to ensure compliance to regulatory and quality requirements of the busine 

General Responsibilities

• Monthly Walk-thru (5s); Appointed as deputy while SM, Quality Assurance is absent, control and Signature of all documents.   
• Manage departmental operating budgets and costs according to annual allocation to ensure efficient usage of resources, where applicable. 
• Manage and oversee the development and implementation of quality assurance procedures, processes and standards to ensure alignment to global DKSH quality policy and local regulatory guidelines. 
• Develop and maintain quality assurance systems (QMS), including the development of quality checklists, supporting tools and techniques 
• Recommend improvement on policies, practices and processes to ensure the attainment of product quality standards. 
• Review and close quality-related complaints, taking corrective and preventive actions to resolve issues. 
• Foster the implementation of a good data management system in accordance with standards of good data safekeeping 
• Conduct quality-related trainings to enhance employees' quality awareness and create a culture of continuous improvement 
• Provide specialist technical advice and support to management and staff on quality assurance matters in accordance with established policies, procedures and legislative requirements 
• Liaise with external institutions for product licensing requirements and certification, and food safety and quality. 
• Lead the Quality Management System (QMS) team which consists of Quality Document Controllers (QDC). 
• Implement and maintain Regulation/Quality/SOPs/clients/ISOs,
• GMP/GSDP requirements in Distribution Activities as well as provideTraining to staffs. 
• Update and follow up the DMR and Risk Management file (ISO 13485).                        
• Follow up and review the Risk Assessment with all functions, make sure complete within timeline. 
• Raise and review Change control to/from all Function
• Release of Products for sales; Approval of Trade return. 
• Cold Chain Responsible (Plan and conducting test cold room drill).
• Control QA’s KPI and send to Regional QA (Monthly).
• Conduct and monitor trace and recall activities (including mock recall for once yearly) to make sure that the work processes are completed with proper documentation. 
• Training to relevant function (Regulation/Quality/SOPs/clients/ISO requirements). 
• Local and Regional internal auditor; Provide quality initiatives and improvement for organization. 
• Others task assign by Manager.

Functional Skills and Knowledge

•  Demonstrate knowledge in quality assurance tools, concepts and methodologies 
• Demonstrate knowledge of relevant regulatory requirements
• Demonstrate knowledge in good manufacturing practice (GMP)/ISO9000 or other quality management systems

Education

• Bachelor of Science or quality-related disciplines
• Certification in Quality Auditor, Quality Engineer, Quality Improvement 
• Associate, Six Sigma would be an advantage