QC-specialist

Job description

  Coordinate testing plan of the raw materials, semi-finished, finished products, validation sample and project sample according to plan, assure the test were carried out on time according to the analytical methods and pharmacopoeia requirements.

按照计划组织协调实验室原辅料，半成品，成品，验证样品和项目样品的检验，确保检验工作按照分析方法和药典要求进行并按时完成。

·  Support the QC manager to carry out the investigation of OOS and assure the appropriate CAPA was made and implemented.

支持QC经理进行实验室检验异常情况的调查并确保制定合适的预防整改措施并实施。

·  Assure the analytical instruments in QC were maintained, validated/verified and calibrated on time. Assure the analytical method in were validated.

确保QC 实验室仪器按时进行维护、验证/确认、并经过校验。确保实验室的分析方法经过验证。

·  Maintain the reference standards as well as the relevant documentation and record. Maintain the reagents and their records.

维护对照品的管理及记录。维护试剂的管理及记录。

·  Draft procedures, qualification protocols of the analytical instruments and the analytical methods. Perform the qualification and validation work.

编写标准操作规程、仪器确认草案及分析方法验证方案。执行验证工作。

·  Implement stability study according SOP and finish stability report on time

负责管理执行稳定性考核工作，并及时完成稳定性考核报告。

·  上级安排的其他工作。

Other works assigned by the leader.

Requirements：

Must to have : 最低要求

Education 教育 : Bachelor degree/ 大学本科

Professional /Major 专业： Pharmacy related major/ 药学相关专业

Experience 经验 : At least 4years QC analysis and 1 year management working experience in Pharmaceutical company. 制药行业 QC 至少 4 年分析工作及 1 年管理工作经验。

Better to have : 优先考虑项

Education 教育 : Postgraduate 研究生

Professional /Major 专业： Pharmacy analyst 药物分析专业

Experience 经验: At least 5 years QC analysis and 3 year management working experience in Foreign pharmaceutical enterprise. 外企制药行业QC至少5年分析工作及3年管理工作经验。

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.