药典检测分析员

岗位要求

最低任职要求Minimum Requirement

教育程度/经验Education background/ Experience

College Degree or above in Chemistry, Biochemistry or other related field.

化学、生物化学或其他相关专业大专及以上学历。

技能Skills

Good project management, time management, and multitasking skills.

Fluent in writing and reading in both Chinese and English.

Good computer operation skill, intermediate level in Microsoft Word, Excel, PowerPoint etc.

其他要求（比如工作时间等）Other requirements (e.g.: working time)

Critical thinking, scientific reasoning and problem solving skills.

工作职责JOB RESPONSIBILITY

按照相关SOP、AMP、检测方法及cGMP要求开展检测工作，包括不限于密封性测试，pH，电导率，外观，渗透压等理化检测。根据需要进行这些方法的方法确认/验证。管理标准品、关键试剂等。

Perform testing in accordance with relevant SOPs, AMPs, test methods, and cGMP requirements, including but not limited to physicochemical tests such as CCIT, pH, conductivity, apperance and osmolality. Perform method verification/validation for these methods as required. Manage reference standards, critical reagents, etc.

开展QC过程控制、放行及稳定性检测。

Perform QC in-process/release/stability testing.

负责起草、升版药典检测相关的SOP以及方法确认，验证类文件.

Responsible for drafting and revising pharmacopoeial testing-related SOPs, as well as method qualification and validation documents.

配合实施实验室仪器设备的确认验证、使用、清洁、维护和校验，确保仪器的有效运行与管理。负责实验室调查、变更，CAPA行动项的执行。

Cooperate to implement equipment, and calibration, utilization, clearance, maintenance, and calibration, and ensure effective operation and management of them. Responsible for laboratory investigation, change, and performing the action of CAPA.

按照GDP要求及时、规范地记录检测过程及结果。

Promptly and properly document tests and results per GDP.

按照5S管理及EHS要求维护实验室环境。

Maintain the laboratory environment according to requirements of 5S management and EHS.

完成主管分配的其他相关工作。

To undertake other tasks assigned by supervisor.