岗位职责：

1.     协助起草和修订药品经营质量管理体系文件，并配合指导和监督文件的执行。

Assist in the draft and revise quality management system documents and

cooperate in guiding and supervising the implementation of the documents.

2.协助实施企业质量体系内审、质量风险审核计划和方案、质量方针和目标实施情况的检查，并协助跟进确认整改措施的有效落实情况。

Assist in the implementation of internal audits of the quality management

system, quality risk review scheme, and inspections of the implementation of

quality policies and objectives and assist in following up and confirming the

effective implementation of CAPA.

3.协助审核购销客户的合法资质、建立客户档案，并进行动态管理，配合实施对购销客户质量管理体系和质量保证能力的审核和评价。

Assist in reviewing and confirming the qualifications of customers, established

customer files, conducted dynamic management, and cooperate in the audit and

evaluation of the quality management system and quality assurance ability of

customers.

4.协助审核购进品种的合法资质，收集和管理产品质量信息，建立产品质量档案，并进行动态维护。

Assist in review and confirm the qualification of purchased products, collected

and managed product quality information, established and improved product

quality files, and conducted dynamic maintenance.

5.协助审查第三方物流在药品储运各环节的质量管理工作及质量保障能力，配合实施对第三方物流的KPI考核和质量审计，及时发现和纠正问题，确保第三方物流提供的药品储运及药品追溯管理符合GSP和双方质量协议的要求。

Assist in reviewing the quality management work and quality assurance

capabilities of third-party logistics in all aspects of drug storage and

transportation, cooperate in the implementation of KPI assessment and quality

audit of third-party logistics, promptly discover and correct problems, and

ensure that the drug storage and transportation and drug traceability

management provided by third-party logistics comply with the requirements of

GSP regulation and the quality agreement between the two parties.

6.协助质量查询、质量投诉、质量事故的调查、处理及报告，不合格药品的确认和销毁管理，以及药品召回的配合实施。

Assist in quality inquiry, quality complaint, quality accident investigation,

handling and reporting, confirmation and destruction management of

non-conforming drugs, and product recall related tasks.

7.配合建立和更新计算机系统质量管理基础数据。

Cooperate to establish and update quality management basic data within the

computer system.

8、配合实施进口产品MAH境内责任人的质量保证相关工作。

Cooperate with the implementation of quality assurance for MAH Domestic

Responsible Entity of imported products.

资历要求：

3年以上药品质量管理工作经验

3+ years of working experience in drug quality management

具备生物学专业知识者优先

Biological knowledge is preferred