Job Responsibilities 工作职责：
1.Develop and maintain a robust and stable Raw Material team, with high productivity.
发展和维护一个高效率、稳定、高产出的原物料团队；
2.Closely monitor the raw material testing status, proactively identify and solve any problem or risk which may cause the delay of raw material release.
密切关注原物料放行状态，主动提前识别并解决可能导致物料放行延迟的任何问题或风险；
3.Ensure all the sampling and testing are completed according to relevant SOP and GMP standard.
确保所有的取样和检测都按照相关SOP和GMP标准执行；
4.Lead all the OOS investigation, deviation investigation, close CAPA, change control in a timely manner.
主导OOS调查、偏差调查，及时关闭CAPA和变更控制；
5.Host internal or outside audit.
接待内部或外部审计；
6.Continuously improve lab operation compliance, efficiency, reduce cost.
持续改善实验室运营符合性、效率和降低成本；
7.Any other tasks as assigned by the department head.
部门负责人安排的其他任务；
8.Comply with the company's information security management related system and requirements.
遵守公司关于信息安全管理的相关制度和要求。
Qualification 任职资格：
1.Bachelor’s/Master’s degree in chemistry, biology or pharmaceutics discipline. For Bachelor, 10+ years. For Master, 6+years’ experience in pharmaceutical company quality control department.
化学、生物学或药学本科/硕士。本科十年以上制药企业QC工作经验，或硕士六年以上经验。
2.Familiar with USP, EP, JP and ChP requirement on drug substance, excipient, packaging material.
熟悉USP，EP，JP和ChP对于原料药、物料和包材的要求；
3.Well versed in chemistry or microbiology based testing, with hands-on experience.
精通化学或微生物检测，有一线操作经验；
4.Thorough knowledge of NMPA, EMA and US FDA GMP practices and regulations.
熟知NMPA，EMA和US FDA GMP法规。
5.Excellent oral and written communication skills in Chinese and English (Read, Write, Verbal) demonstrated by communicating with other functions.
良好的中英口语和写作能力与其他各部门顺畅沟通。