Essential Duties and Responsibilities: 基本义务和职责:

1.Ensure that raw material, packing material, semi-product and finished product meet the registration standard and quality spec. 确保原辅料、包材、中间产品和成品符合注册要求和质量标准；
2.Responsible for the establishing, implementation and maintenance of quality management system (QMS), and report the operation status and improvement requirement of QMS to ensure it meets the requirement of regulatory and Corporate Quality Manual (CQM), and continuous improvement. Monitor the GMP implementation of drugs and medical devices. 负责建立、实施并保持质量管理体系，报告质量管理体系运行情况和改进需求，确保质量体系运作符合法规要求和百特总部质量手册，并持续改进；监督药品及器械GMP 的执行情况。
3.Manage customer complaint system, ensure all quality related complaints are investigated and handled in a timely and correct manner, ensure proper action will be taken for customer satisfaction. 管理客户投诉系统，确保所有与质量相关的投诉已经过调查，并及时、正确的处理；确保采取适当的措施来提高客户的满意度；
4.Responsible for approval of raw material and product release, ensure that materials or products are in full compliance with release requirements；Ensure all necessary tests to be completed, and all deviation and OOL have been investigated and disposed；Responsible for approval of materials and product’s internal specification; Responsible for approval of nonconforming products disposal; Responsible for product recall approval. 负责物料及产品放行批准，确保物料或产品已完全符合放行的要求；确保完成所有必要的检验，确保所有重大偏差和超标已经过调查并得到及时处理；负责物料及产品内控标准批准；负责不合格品处理的批准；负责产品召回的批准；
5.Review and approve quality related documents and quality related change. 审核和批准质量管理的文件、以及质量相关的变更；
6. Ensure all necessary verification and validation are completed, review and approve protocol and report. 确保完成各种必要的确认或验证，审核和批准方案和报告；
7.Assess and approve suppliers of material, ensure that all suppliers meet Baxter’s requirement. 评估和批准物料供应商，确保供应商符合百特要求；
8.Supervise the maintenance of facilities and equipment to ensure it runs in a good condition; Have veto power over critical equipment selection. 监督厂房和设备的维护，以确保保持其良好的运行状态；对于关键设备选取具有否决权；
9.Ensure that stability study for product is continued. 确保完成产品的持续稳定性考察计划；
10.In the process of product quality management, take the initiative to communicate and coordinate with drug and device management departments, including but not limited to the following work.  在产品质量管理过程中，应主动与药品、器械管理部门进行沟通和协调，包括但不限于以下工作：
➢Shall assist the external inspection team to carry out the inspection. After the inspection, urge company to complete the inspection report and submit to the inspection unit timely. 公司接受外部的相关检查时，协助检查组开展检查；并在检查结束后，督促公司及时回复检查报告；
➢Ensure every year truthfully and timely report the implementation of GMP, annual quality review analysis of drug, implementation of device quality system and annual quality review analysis of device to the drug and/or device supervision and management department; ensure annual report is reported in a timely manner after being approved by the legal person or plant manager. 确保每年应如实并及时向药品、器械监督管理部门上报公司药品GMP 实施情况、年度质量回顾分析情况，器械质量体系实施情况、年度质量回顾分析情况；确保年度报告经法人或企业负责人批准后及时报告。
➢Urge related departments of the company to perform the ADR’s monitoring and reporting of drug and AE’s monitoring and reporting of Medical Device. 督促公司有关部门履行药品不良反应的监测和报告以及器械不良事件的检测和报告的职责。
11.PRRC Responsibilities are as follows: 作为PRRC承担以下职责：
➢Ensuring conformity of the device is checked in accordance with the Quality Management System (QMS) before release.确保产品放行前按照质量管理体系 (QMS)的要求检查产品的符合性；
➢Ensuring technical documentation and EU Declaration of Conformity (DoC) are drawn up and kept up to date.确保技术文档和欧盟符合性声明 (DoC)的及时更新；
➢Ensuring Post-Market Surveillance (PMS) obligations are met.确保上市后监督 (PMS)义务的履行；
➢Ensuring reporting obligations relating to vigilance are met (ref. Article 87 to 91 of MDR).确保履行与警戒相关的报告义务（参见 MDR 第 87 至 91 条）；
➢Ensuring that the Declaration for investigational device(s) used in clinical trials conforms to General Safety and Performance Requirements (GSPR) apart from aspects covered by the clinical investigations.确保临床试验中使用的研究器械产品的声明符合一般安全和性能要求（GSPR），除了临床研究涵盖的方面。
12.As a member of the drug safety committee, be responsible for major risk assessment, major or emergency drug incident disposal, risk control decision and other major matters related to pharmacovigilance.作为药品安全委员会成员，负责重大风险研判、重大或紧急药品事件处置、风险控制决策以及其他与药物警戒有关的重大事项。
13.Ensure all employee related to product quality have passed necessary job training and re-training；确保企业所有与产品质量相关人员都已经过必要的上岗培训和继续培训；
14.Ensure self-check and product quality review are completed.确保完成自检和产品质量回顾分析；
15.Monitor all factors which will affect product quality, include the storage condition for material and product.监控影响产品质量的因素，包括物料和产品的贮存条件等；
16.Approve and monitor the OEM production and delegation inspection if applicable.批准并监督委托生产和检验。

其他信息

行业要求：全部行业
所属部门：质量部