岗位职责:

1.能够严格按照 SOP 操作并及时准确地完成各项 QC 检测分析，包括 HPLC/UPLC，CE，UV，pH, iCIEF 及其他常用理化分析方法。

Responsible for QC tests ,including HPLC/UPLC, CE, UV, pH, iCIEF and other physicochemical analysis, with strictly accordance with the SOPs and GMP rules.

2. 能够支持或独立完成分析方法的转移、验证和确认。

Responsible for the transfer, validation and qualification of the analytical methods.

3. 负责汇报和处理各类质量事件的调查及处理，如 OOS、偏差和纠正预防措施等。

Report and handle routine quality events investigation procedure in operation process such as OOS, Deviation, and CAPA, etc.

4. 完成实验室仪器和环境日常的使用和维护。

Responsible for daily maintenance of lab equipment and environment.

5. 负责起草、修订、审阅实验室文件，如：SOP、验证方案、确认报告等。

Establish, revise and review the Lab documents such as SOP, validation protocol, qualification reports and etc.

6. 确保日常行为符合 GMP 以及公司规章制度要求。

Ensure behaviors in compliance with GMP and the company rules and regulations.

7. 完成上级主管交付的其他任务。

Complete other tasks assigned by the supervisor

任职要求:

1.本科学历及以上，药学或者相关专业；英语四级以上。有制药行业工作经历。

College degree or above, major in pharmacy or related with industry experience for over 2 years in or related field; CET-4 or above.

2. 具有基本的理化实验和设备的操作技能，如 pH 测试，CE，iCIEF 等。具有能独立分析和解决问题的能力

Basic operation skills of physicochemical experiment and instruments, such as pH test, CE, and iCIEF, etc. Independent analysis and problem-solving skills

3. 了解药品 GMP 规范或具备制药企业相关经验。

Knowledge of GMP or relevant experience in pharmaceutical industry.

4. 为人正直严谨，具备良好的沟通能力和团队合作精神。有一定的抗压能力。

Honest and rigorous, with good communication skills and team spirit, be able to work under pressure.