岗位职责 Main Responsibilities

1. 负责组内的工作并解决工作中的问题。

Responsible for the work within team and solve problems occurred in routine work.

2. 负责领导和执行分析方法开发，验证、分析仪器的确认及/或领导进行原料和产品的质量控制等工作。能很好的指导分析员完成工作。

Responsible for leading and performing method development, validation, instrument qualification and quality control of raw material and product, and is able to guide the analyst to finish the job in good manner.

3. 负责仪器设备的正常运行和维护，配合主管审定本组所需试剂及备件，配合采购完成采购任务。

Responsible for equipment in good operation and maintenance, cooperate with the manager to determine requirement of reagents and spare parts, and work with purchase group for purchase task.

4. 负责样品的分析测试并出具分析报告。

Responsible for sample test and draft testing report.

5. 负责产品稳定性试验方案的制定并按方案进行稳定性测试，为原料药的有效期或复验期及贮存条件的制定提供依据。

Responsible for establishing stability study protocol and perform stability test according to protocol, provide evidence for shelf life or re-test date and storage condition establishment.

6. 协助其他工厂分析实验室的分析工作；做好方法转移，培训当地分析员并协助解决分析中遇到的问题。

Provide assistance of analytical work in other site labs; Perform method transfer and train the local analyst and solve problems in testing work.

7. 负责制定分析用仪器、设备、试剂、试液、标准品（或对照品）、标准液、培养基和菌种的管理办法，并按规定实施。

Responsible for establishing the management protocol of analytical instrument, equipment, reagent, solution, standard (or reference material), medium and strains, and execute according to protocol.

8. 撰写并审核分析文件，例如分析方法，方法验证方案，报告和标准操作规程等。

Draft and review analytical documents, such as test method, method validation protocol and report and standard operation procedure, etc.

9. 遵守相关的操作规程和安全规程。

Follow related operation procedure and safety protocols.

10. 协助QA做好本部门的cGMP培训并遵守cGMP的有关法规。

Assist QA for cGMP training and follow relevant cGMP regulations.

11. 制定内部培训计划，定期进行技术培训及专业培训。

Make internal training plan, and provide training technical and professional knowledge periodically.

任职资格 Qualification

1.教育背景：药学、生物、医学检验等相关专业

Bachelor degree or above inpharmacy, biology, medical examination or other related fields

2.至少3年以上制药企业QC微生物相关检验经验，2年以上管理经验；英语听说读写熟练，熟悉GMP要求，熟练使用Microsoft office办公软件。

Minimum 3 years of microbial testing experience in Quality control department in pharmaceutical company, at least 2 years of lab management working experience; fluent in English (both oral and written), familiar with GMP requirement, skilled in Microsoft office software.