质量授权人

岗位职责：
1.Verify alignment between the quality operations and RA activities related to the EU product marketing authorizations and EU GMP requirements.

确认质量运营、与欧盟产品上市许可相关的法规事务活动与欧盟GMP要求相符合。

2.Participate when required, on the qualification and monitoring process of all suppliers providing services for the production and testing of EU products (i.e. Third party laboratory qualification, primary packaging components, and APIs suppliers).

需要时，参与为欧盟产品生产和测试提供服务的所有供应商(例如，第三方实验室确认、内包装组件和API供应商)的确认和监测过程中。

3.Ensure there is no gap between site quality/operations system and EU client quality and supplier agreements.

确保现场质量/运营系统与欧盟客户质量和供应商协议之间无缝对接。

4.Work hard to hand with the engineering TTD department, laboratories, and customer’s Qualified Person for the transition of EU products to manufacturing.

努力与工程部技术转移部门、实验室及客户质量授权人合作，将欧盟产品转移到现场生产。

5.Responsible to overview the assembly and presentation of the site Annual Product Review in accordance to written procedures.

负责按照书面规程概述现场年度产品审核的汇总和展示。

6.Manage and present site Metrics in the Monthly Management meetings.

管理现场指标和阅读管理会议。

7. Acts as primary on- site CMO host and EU regulatory inspections.

作为首要的现场委托加工机构主持人和欧盟法规检查员。

8.Acts as primary on-site CMO and client routine audits and Qualified Person on-site visit.

作为首要的现场委托加工机构主持人、客户日常审计人员和现场参观的质量授权人。

9.Establishes, refines, implements, and maintain proper QA system and procedures for the company’s compliance with EU GMP-CMO operations.

建立、细化、执行和维护适当的质量保证体系和规程，以使公司符合欧盟GMP-委托加工机构运营。

10.Ensure that the systems affecting product quality for product marketing in Europe (e.g. batch records, testing, SOPs, validation protocol/reports) are consistent and in full compliance with customer requirements and that the customer’s Qualified Person is part of the change control process.

确保影响在欧洲销售产品的产品质量的各个系统（例如，批记录、检测、SOPs、验证方案/报告）的一致性并完全符合客户的要求；确保客户的质量授权人是变更控制流程的一部分。

11.Design and implement a process flow to ensure data governance review is always observed.

设计并执行工艺流程，确保始终遵循数据管理评审。

12.Final verification of Master batch records, Material Specifications for APIs, components, label/labeling components, excipients, and Finished products batch records to ensure all activities such as sampling, testing, environmental monitoring, production instructions, and yields have been properly documented, and that the storage requirements are in accordance to the materials and finished products requirements.

审核并批准欧盟产品主批次记录、APIs、组件、标签/贴标组件、辅料及成品的物料质量标准，确保抽样、检测和储存要求符合物料及欧盟要求。

13.Certified, and provide EU product batch records to the Qualified Person ensuring that the product has been released after the verification of data and data integrity review following the EU GMP requirements.

证明，并向质量授权人提供欧盟产品批记录，确保产品按照欧盟GMP要求进行数据确认和数据完整性审核之后被放行。

14.Work closely with the RA department on the review and assembly of regulatory documentation for client’s QP regulatory submissions.

与法规事务部紧密合作，为客户质量授权人递交法规申请，审核并装订法规记录。

15. Evaluate, compile, and provide the annual product data trending and/or raw data upon EU- QP client’s request for EU product reviews.

欧盟-质量授权人要求对欧盟产品进行审核时，评估、汇编并提供年度产品数据趋势和/或原始数据。

16.Participate in the Monthly Management Meeting.

参加月度管理层会议。

17.Responsible for leading the site Risk Management Process.

负责领导现场风险管理流程。

18.Maintains job proficiency and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks and participate in professional societies.

通过参加教育研究班，查阅专业刊物，建立人脉网络，参加专业协会，精进工作能力和专业知识。

19.Complete any other work task assigned by superior or designee.