职位职责：

1.分析文件审核和批准.Analytical Document Review and Approval.

2.审核和批准分析部门起草的质量标准、分析方法、分析方法验证方案和报告、分析报告（CoA）等文件。Review and approve Specification, Analytical Method, Method Validation Protocol and Report, Certificate of Analysis (CoA) documents drafted by analytical department.

3.审核和批准分析方法技术转移方案和报告。Review and approve the analytical technique transfer protocol and report.

4.审核和批准批产品放行检验记录模板、执行后的批检验记录，以及分析数据报告单。负责与产品放行检验相关的审计追踪的上机审查。Review and approve batch release testing record template, executed batch release testing record and CoA. Responsible for review the audit trail related to the product release testing.

5.审核和批准稳定性方案、记录和报告。Review and approve the stability protocol, record and report.

6.负责审核分析部门相关的SOP文件。监督SOP的执行情况，确保质量控制系统按照SOP要求在分析实验室被正确执行。Responsible for review SOP files related to analytical, check the SOP and to ensure proper implementation of the Quality Control system as per SOP in AN Lab.

7.按照SOP对GMP分析文件进行接收、登记、复印、分发、收回、借阅、作废、销毁。Receive, register, copy, distribute, recall, lend, obsolete and destruct GMP analytical documents according to SOP requirements.

8.参与分析相关的项目管理。Participate in project management related to analysis.

9.参与分析相关的变更、OOS、偏差和异常事件的登记、报告审核。Participate in registration and the report review of Change Control, OOS, Deviation and Occurrence Investigation related to analytical department.

10.审核和批准软化水和纯化水检验记录和报告。Review and approve softened water and purified water testing record and report.

11.定期审核分析实验室的Vaisala数据。Periodic review the Vaisala data from AN Lab.

12.参与分析实验室的日常巡检工作，完成巡检报告，监督巡检报告中整改项的实施。Participate in the routine inspection of AN Lab, and form a report. Supervise the implementation of corrections of the inspection reports.

13.完成本部门领导临时安排的工作。Complete any interim arrangements arranged by the leadership of the department.

职位要求：

1.教育背景：化学、分析化学、药学或其他相关专业本科及以上学历。Education: Bachelor degree or above in chemistry, analytical chemistry, pharmacy or other related fields.

2.经验：至少1年从事药品检验实践经验，具有良好药品检验GMP知识和经验，接受过与药品分析和实验室GMP相关的专业知识培训。Experience: At least 1 years of experience in drug testing, good drug testing GMP knowledge and experience, and professional knowledge training related to drug analysis and laboratory GMP.

3.技能：具有一定的英语能力，应能阅读USP/EP/ICH等药品分析相关的专业资料。Skills: with a certain degree of English ability. I should be able to read professional materials related to drug

analysis such as USP/EP/ICH.