岗位职责

1.直接下属4人。负责实验室QA团队的人员管理，工作安排，绩效管理，团队建设与人才培养。There are 4 direct reporting QA specialists. Responsible for personnel management, work arrangement, performance management, team building and talent development of the laboratory QA team.

2.负责QC理化实验室与微生物实验室以及AD实验室的QA监管。Responsible for QA supervision of the QC physical/chemical laboratory, microbiology laboratory, and AD laboratory.

3.负责批准质量标准，分析方法及CoA。Responsible for approving the issued specification, analysis method and CoA.

4.负责实验室标准操作规程的审核与批准。Responsible for reviewing and approving the standard operation procedure.

6.负责分析实验室OOS，异常事件，偏差及变更的审核与批准。Responsible for review and approving the OOS, OR, deviation and change control in analytical laboratory.

7.负责分析实验室检测数据审核批准，分析仪器验证报告的审核批准。Responsible for review and approval of analytical laboratory test data and analytical instruments qualification reports.

8.负责分析方法验证的方案和报告批准。Responsible for review and approving the method validation protocol and reports.

9.负责确保分析实验室的日常监督检查有效执行，批准巡检报告.Responsible for ensuring the effective implementation of routine inspection in the analytical laboratory and approve the routine inspection reports.

10.负责合同实验室的管理及审计。Responsible for contract laboratory management and audit.

11.起草分析实验室管理相关的质量管理文件。Draft quality management documents related to the management of analytical laboratories.

12.参与客户审计及相关准备工作。Participate in customer audits and related preparation work.

13.完成领导安排的其他工作。Complete the work assigned by leaders.

任职资格：

1.本科或以上学历，化学、药学、制药工程等相关专业。 Bachlor or above degree in chemistry or pharmaceutical or related majors.

2.五年以上制药或CRO行业QA+QC工作经验。熟悉理化、微生物实验室工作流程与要求，AD实验室的方法验证工作，有丰富的实验室调查与偏差调查经验，At least 5 years of QA+QC working

experience in the pharmaceutical or CRO industry, be familiar with the process and requirements in QC physical/chemical laboratory, microbiology laboratory and method validation in AD lab, with experiences of lab investigation and deviation investigation.

3.具有领导力，能带领团队高效完成业绩，支持团队进行跨部门、跨场区沟通与问题解决。有QA或者QC团队管理工作经验优先考虑.Have leadership skills and be able to lead the team to achieve excellent performance. Support the team in conducting cross-departmental and cross-site area communication and problem-solving. Prior experience in QA or QC team management is preferred.QA or QC team management experience is preferred.

4.熟悉ICH Q7,GMP等相关法规。 Familiar with ICH Q7, GMP and relevant regulations.

5.有很强的工作条理性、计划性及任务执行能力。具有很强的跨厂区、跨部门沟通能力，团队协作意识和沟通技巧。Have a strong work logic，planning ability and strong ability of task execution. Have strong ability of cross-site & cross-department communication, sense of teamwork and communication skills.

6.英语口语流利。Fluent in oral English.