工作职责：

KEY ROLES AND RESPONSIBILITIES:
• Support China quality lead for quality management system’s implementation and maintenance to make sure it’s complaint to company QMS and local regulation requirements.
• Be responsible for product local release activities to ensure timely delivery of products.
• Be responsible for new product launch support from quality’s perspective.
• Provide support to ensure related process is in place which meets drug and MD GSP requirements.
• Provide support to set up quality system for Domestic Responsible Entity which meets DMAH regulation requirements.
• Support inspection / Audit readiness to ensure Health Authority inspections and Divisional inspections.
• Conduct the company quality system internal audit, investigation on the audit findings and CAPAs development for quality management system continuous improvement.
• Communicate with 3PL to ensure the product quality during storage, maintenance and transportation, etc.
• Be responsible for drug Annual reporting process and working with RA, PV and SCM etc., to make sure timely submission
• Perform other related duties as assigned by management.

任职资格：

MINIMUM QUALIFICATIONS, SKILLS AND EXPERIENCES
• At least have bachelor’s degree of pharmaceutical or related education background
• At least 5 years of experience of quality, compliance or other relevant experience in pharmaceutical industry
• Prefer to have working experiences in MNC pharmaceutical Drug Distribution company
• Effective English skills for communication in verbal and writing
• Effective communication skills