QA Facilitator

Management of QA affairs

QA 日常业务的处理    -     Handling,  investigation and assessing of quality issues

       质量事件的处理，调查和评估

-     Establish, execute and track CAPA

CAPA的建立，执行和追踪

-     Review batch production report

       审核产品的批记录

-     To be involved in regulatory inspections and self-inspection

       参与审计和自检

-     Ensure to fulfill the KPIs of QA

       确保完成QA的部门目标

-     Identify the quality risk during daily work, improve continuously.

识别日常工作中的质量风险点，持续改善。

-     Support PET business processes regarding compliance and quality

就法规符合性和质量给予PET业务支持

-     Communicate with other AZ sites regarding to quality issues

与其他AZ基地有关质量问题进行联络

-     Ensure all the warehousing and distribution activities comply with the GXP requirement.

确保仓储和收发货活动符合GXP的要求。

-     Facilitate local vendor management and give support to GES/GDMS group

对本地供应商进行管理并为GES/GDMS在中国的业务提供帮助

Additional requirement for Authorized Release QA Engineer

对于负责产品放行的QA工程师的额外要求

-     Release RM, GF and CMO products

释放原辅料、GF和CMO的产品

-     To maintain a smooth product release procedure

维护流畅的产品放行程序

-     When take charge of the docs/samples archivist role:

承担文件/留样房间管理员角色时：

Ensure each team can follow document/sample archiving rooms’ procedures to conduct any archiving activities

负责确保各团队能够按照各档案室、留样间的标准操作规程进行档案/样品的管理活动

Ensure each team record all the activities and keep the proper track of docs/samples

负责确保各团队做好相应的记录，保持对档案/样品正确状态的可追踪性。

Quality system management

质量体系管理       -     Draft, review and approve document to make sure in compliance with GMP requirement

起草和审核文件确保符合GMP的要求

-     Annual product review

       年度产品回顾

-     Own QA procedure, secure operation GMP compliance

负责QA流程，确保运行的高度符合GMP

-     Lead and execute Change Control

负责和实施变更控制

-     Quality continuous improvement

质量的持续改进

People Management

人员管理       -     Provide Coaching for peer and team member to handle QA affairs

指导团队成员处理QA日常业务

SHE responsibilities

安全环境健康责任       -     Identify and understand the SHE risk factors within the department

识别和认识本部分的安全危险因素

-     Develop and carry out plans to address the key SHE issues in the associated areas and ensure the follow up actions are carried out.

制定和执行SHE方案以强调在相应区域的关键SHE事件并确保跟进措施的落实执行。

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorisation and employment eligibility verification requirements.