岗位职责：
1.起草并完善公司药品经营质量管理体系文件，并培训、指导和监督文件的执行。
Draft and improve quality management system documents,and train, guide and supervise the implementation of the SOPs.
2.实施企业质量体系内审、质量风险审核、质量方针和目标实施情况的检查，并督促整改措施的有效落实。
Implement the internal audit of QMS, quality risk assessment, quality policy and target implementation inspection, and supervise the effective implementation of rectification measures.
3.审核购销客户的合法资质、建立客户档案，并进行动态管理，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。
Review and confirm the qualifications of customers, established customer files, conducted dynamic management, and organized the audit and evaluation of the quality management system and quality assurance ability of customers.
4.审核购进品种的合法资质，收集和管理产品质量信息，建立健全产品质量档案，并实施动态维护管理。
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.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，开展对第三方物流的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适用法律法规和双方质量协议的要求。
Review the quality management work and quality assurance ability of the third-party logistics in all aspects of drug storage and transportation, carry out KPI assessment and on-site audit of the third-party logistics, timely find and correct problems, and ensure that the drug storage、transportation and traceability management provided by the third-party logistics meets the requirements of applicable laws and regulations and the quality agreement of both parties.
6.负责质量查询、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，并建立相关记录。
Responsible for quality inquiry, quality complaint, quality accident investigation, treatment and report, unqualified drug confirmation and destruction management, and create related records.
7.指导设定计算机系统的质量控制功能和计算机系统操作权限，建立和更新质量管理基础数据。
Guided the setting of the quality control function and operation authority of the computer system, established and updated the basic data of quality management.
8、配合实施进口产品境内责任人的质量保证相关工作。
Cooperate with the implementation of quality assurance related work for Domestic Responsible Entity of imported products.
资历要求：
本科及以上学历，药学或相关专业，生物制药类专业优先
Bachelor degree or above in pharmacy or related field，priority to Biopharmaceutical major
3年以上药品经营企业质量管理经验
Work experience of more than 3 years in drug operation and quality management
具有执业药师资格
licensed pharmacist
良好的中、英文书面及口头沟通能力
Written and oral communication skills in both Chinese and English