
工作职责:
- Support China quality lead for quality management system’s implementation and maintenance to make sure it complaint to company QMS and local regulation requirements
- Be responsible for maintenance/change application process of Drug Distribution License and MD Distribution License
- Provide critical support to ensure related process is in place which meets GSP 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.
- Manage GSP/GDP Training system to ensure training and qualification to related employees are sufficient and comprehensive
- Be the key person on 3PL distribution quality lifecycle management contact to ensure the product quality during storage, maintenance and transportations etc.
- Lead Drug Annual reporting process and working with RA, PV and SCM etc., to make sure timely submission
- Be responsible for product local release activities to ensure timely delivery of products
- Perform other related duties as assigned by management
任职资格:
- At least have bachelor degree of pharmaceutical or related education background
- Must be the China Licensed Pharmacist
- 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