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助理质量管理经理
15-23K/月上海市-上海/本科及以上/5-10年
任女士今天来过
第一三共（中国）投资有限公司
职位详情
岗位职责
工作职责：
1.起草并完善公司药品经营质量管理体系文件，保证公司的质量体系文件符合国家药品经营相关法律法规的要求及公司实际，并培训、指导和监督文件的执行。
Draft and improve quality management system documents, ensure it comply with the requirements of the laws and regulations on drug distribution and the actual situation of the company, and train, guide and supervise the implementation of the documents.
2.起草并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，对发现的缺陷项提出整改意见，并督促和指导整改措施的有效落实。
Draft and implement the internal audit of QMS, quality risk audit plans and programs, quality policy and target implementation inspection, put forward rectification suggestions for the defects, and supervise and guide 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，组织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，并进行动态维护。
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GSP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 GSP 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，以及药品召回的配合实施。
Responsible for quality inquiry, quality complaint, quality accident investigation, treatment and report, unqualified drug confirmation and destruction management, and drug recall cooperation.
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MAH境内代理人的质量保证相关工作。
Cooperate with the implementation of quality assurance for MAH domestic agents of imported products.
任职资格：
1.药学或相关专业本科学历 Bachelor degree, in pharmacy or related field
2.3年以上药品质量管理经验 work experience of more than 3 years in drug quality management
3.具有执业药师资格 licensed pharmacist
1.起草并完善公司药品经营质量管理体系文件，保证公司的质量体系文件符合国家药品经营相关法律法规的要求及公司实际，并培训、指导和监督文件的执行。
Draft and improve quality management system documents, ensure it comply with the requirements of the laws and regulations on drug distribution and the actual situation of the company, and train, guide and supervise the implementation of the documents.
2.起草并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，对发现的缺陷项提出整改意见，并督促和指导整改措施的有效落实。
Draft and implement the internal audit of QMS, quality risk audit plans and programs, quality policy and target implementation inspection, put forward rectification suggestions for the defects, and supervise and guide 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，组织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，并进行动态维护。
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GSP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 GSP 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，以及药品召回的配合实施。
Responsible for quality inquiry, quality complaint, quality accident investigation, treatment and report, unqualified drug confirmation and destruction management, and drug recall cooperation.
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MAH境内代理人的质量保证相关工作。
Cooperate with the implementation of quality assurance for MAH domestic agents of imported products.
任职资格：
1.药学或相关专业本科学历 Bachelor degree, in pharmacy or related field
2.3年以上药品质量管理经验 work experience of more than 3 years in drug quality management
3.具有执业药师资格 licensed pharmacist
任职要求
无
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公司信息
第一三共（中国）投资有限公司
- 上海
- 10000人以上
- 生物制药
- 外企
- 无
第一三共致力于通过运用我们全球一流的科学技术，创造新的模态与创新药物，以实现“为提高世界各地人们的生活质量做出贡献”的目标。除了目前的癌症与心血管疾病药物组合外，第一三共还专注于为癌症患者以及其他医疗需求未得到满足的疾病患者开发新疗法。凭借自身120多年的科学专业知识和覆盖20多个国家的业务范围，第一三共及其全球17,000名员工将秉承公司深厚的创新传统，努力实现我们的2030年愿景，成为“为社会可持续发展做出贡献的创新型全球医疗保健公司”。欲了解更多信息，请访问：www.daiichisankyo.com。
