Maintain the QMS of China MCOQ to ensure the compliance to AstraZeneca QCM &standards and GSP regulations regarding to China trading companies.
Serve as quality liaison to the drug regulatory agency (if required), support GMP&GDP audits and inspections, and support the smooth closure of inspections.
To maintain / improve efficient product batch evaluation procedure to ensure the product supply is maintained at a high-quality standard.
Responsible for China MCOQ Wholesaler Quality Life Cycle Management.
Responsible for China MCOQ product/ Wholesaler/ service suppliers Quality Assurance Agreement (QAA) Quality Life Cycle Management.
Responsible for the quality events handling during the daily business, including but not limited to deviation, complaint, etc.
Lead, facilitate and support key business processes on behalf of QA in supply chain.
To be part of global vendor program management, support imported finished products management and work with sending site QA, EQ and global cooperate quality.
Responsible for the achievement of quality KPIs and objectives/Quality Plans. Ensure adverse trends related to quality compliance are addressed through development of continuous improvement plans.
Support QMS compliance and continuous improvement in China MCOQ , actively identify issues, concerns, and risks and escalate timely.
Contributes to development procedures in area of specialism and provides some technical input into the development of global standards for function and globally.
Leads trouble shooting activities to resolve existing problems, make complicated judgements and anticipate future developments in AstraZeneca’s Quality related needs.
Drive the quality process improvement and simplification as quality business process champion, ensuring GMP/GDP/GSP compliance and AZ global standard compliance.
Identify and understand the SHE risk factors within the department.
Requirements：
Chemistry, Digitalization. Licensed pharmacist is preferred.
10+ years prior experience in GMP/GSP/GDP and compliance management environment.
5+ years’ experience of supplier quality management or distribution quality management.
Experience of working cross functionally across the supply chain with groups such as regulatory affairs, manufacturing, supply, and account management, etc.
Overall quality management system and GMP/GSP/GDP knowledge.
Expert of GMP/GSP and market company quality systems.
Experienced in Digitalization
Expert of quality management system key process and quality risk management.
Wide network in the industry and local authority.
Good collaboration, team coaching and people development capability.
Good command of English.
Good Computer skill.
Good communication skills, proactive leadership, strong quality, and service minds.