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Job Responsibilities: 1. Manage end-to-end customer complaints. Monitors trends, related metrics and initiates actions for improvement. 2. Evaluate and assess product quality before distribution 3. Support business team on customer request related to Quality department 4. Work closely with cross-functional teams in overseeing and providing regulatory/compliance guidance on operational activities (including customer complaints handling and supplier/subcon management). 5. Monthly data analysis on product quality and quality objective 6. Drive continuous improvement initiatives to enhance product quality, process effectiveness, and QMS compliance. 7. Provides Quality support local labeling operation to ensure compliance to internal procedures and local regulations. Initiates actions for improvement. 8. Ensure compliance with ISO 13485, FDA regulations, customer requirements, and applicable quality standards. 9. Lead for site’s NC/CAPA management. Responsible for ensuring process is followed and records are managed in a timely manner with proper investigation, root cause analysis and corrective and preventive action taken. Monitors related metrics and initiates actions for improvement. 10. Conduct and support training activities to cross-functional team in the country in alignment with corporate QMS requirements 11. Execute Field Corrective Action (FCA). Ensure timely follow-up, execution and completion of necessary actions 12. Support in maintaining effective Quality Management System (QMS) 13. Support audit(s) regularly to ensure effectiveness of QMS 14. Support regional Quality Compliance leader to drive and implement any improvement project 15. Other such duties that may be determined by management. Qualifications: • Bachelor’s degree in Pharmaceutical, Pharmacy or Science or equivalent • Has analytical skill, able to interpret information and data for routine operational needs. • Has good understanding on ISO 13485:2016 or Thailand GDP/GDPMD • Minimum 5-10 years’ experience in Quality function • Certified ISO 13485 auditor is preferred • Experience with project management is preferred • A registered Pharmacist is preferred • This role is required to support activity in other countries in Southeast Asia remotely