Minimum Qualification of the QA Assistant QA Assistant任职要求

EXECUPHARM hereby represents and warrants that the QA Assistant has the relevant qualifications and capability to perform such monitoring service according to medical device regulatory requirements.

翼科在此声明并保证，根据医疗器械相关的法规要求，QA Assistant具备相关资质和能力来完成上述服务工作。

Services 服务

QA Assistant shall perform the following services:

QA Assistant须开展以下服务：

？ Translate the global documents, related records and reports

总部文件、相关记录及报告的翻译

？ Communicate and tracking the implementation of case (inquiry and complaint) handling requirements

协助沟通和跟踪各项事件(问询及投诉)处理要求在中国的执行

？ Communicate and tracking the implementation of Recall action in China Mkt.

协助跟踪召回行动在中国的执行进度。

？ Review the product quality compensation request

协助复核产品质量补偿申请

？ Documents & Records Management and Archive

相关文件及记录的整理和分类归档

？ MRA internal/external WeChat Management.

负责部门内外部微信公众号管理

？ Arrange classroom training for PMS topic.

负责上市后监管相关课程的现场培训安排。

COMPANY shall provide the necessary tools and assistance for the QA Assistant to perform the services as stated hereinabove. The required assistance from COMPANY includes but not limited to:

• Provision of project training e.g. process training, product training

提供项目培训，如流程培训、产品培训

• Overall supervision

全面监督

1. KEY TASKS/ACCOUNTABILITIES

？ Cooperate with related dept. to complete the assigned work and meet the Roche requirements.

积极主动与各相关部门合作，完成分派的工作任务，达到公司要求。

？ As a member of PMS team, provides active and strong process supports to internal department as needed

作为PMS团队的一分子，积极为各部门和内部员工提供及时和有力的上市后相关流程支持。

？ Initiatively deals with daily works. Keeps records. Has clear filing and maintain of all documents.

积极主动处理其他日常事务。做好工作记录。文件分类归档，保留完好。

？ Other projects or tasks assigned by line manager

其他主管指派的任务。

？ Conduct business in full compliance to Behavior in Business and Behavior in Competition

遵循商业行为准则，合理合法开展业务活动。

上班地址：张江工业园区