QC Supervisor（Chemical）-Quality-Beijing

Job description

KEY ACCOUNTABILITIES

Manage the Physical&Chemical Laboratory ensuring that the equipment is functional (calibrated and well maintained) and suitable for analytical testing. (10%)

管理理化实验室，确保仪器适合分析测试（得以校正和良好的保养）。

Write and maintain documents such as Analytical Methods, Material Specifications, Standard Operating Procedures, etc. (15%)

编写和保管分析方法、物料质量标准、标准操作规程等文件。

Manage workload and resources to ensure timely release of product. Manage the sampling and analysis of raw materials, intermediates, work-in-process, finished products, routine monitoring samples and others. Ensure that testing is carried out in compliance with specifications, Pharmacopeia requirements and the cGMP and analyse the trend of the analytical results. Ensure the OOS investigation is conducted properly. Release the Raw materials, Packaging materials and Semi-product(Imported) according to the test results. （20％）

根据工作量予以合理安排以保证及时放行产品。管理原辅料、中间体、中间制程产品、成品及日常需监控的样品等的取样和分析。确保执行的检测符合质量标准、药典的要求和GMP的要求，并分析检验结果的趋势。确保正确执行对“超出质量要求的实验结果”的调查。根据检验结果放行原辅料、包装材料及进口半成品。（20％）

Ensure that Reference Standards as well as Standard Solutions are suitable and maintained according to the cGMP. Maintain and control the inventory of chemicals and consumables, including toxic reagents, ensuring that the budget is respected.（10％）

确保标准品和标准试剂适当并按照GMP要求进行保管。保管和控制库存的化学品和耗材，包括毒品试剂，确保将其控制在预算范围内。

Write the Protocols and perform the Qualification of the laboratory equipment/instruments and the Validation of new Analytical Methods. （10％）

编写方案并执行实验室仪器设备的确认和新的实验方法的验证。

Manage the Stability Program. Ensure the retention samples management meet requirements. （5％）

管理稳定性实验计划。确保留样的管理符合要求。

Ensure all the imported material/product are sampled and analysed by BIDC according the local requirements. Maintain the file of BIDC CoAs. （5％）

确保所有进口物料及产品按照中国法规要求被北京药检所取样和检验。保存药检所出具的检验报告书。

Keep close relationship and communication with other departments to ensure proper execution of the production plan. Lead and motivate the analysts for a continuous improvement of GMPs as well as HSE awareness. Be the Safety contact for the Laboratories. （5％）

与相关部门保持密切联系和沟通以确保生产计划的执行。领导并激励实验室人员不断改进和完善GMP和环境/健康/安全程序。作为实验室安全事务联络人。

GAP analysis for global requirement and local regulatory and take CAPA actions. Contribute to internal & External inspections （5％）

总部要求及本地法规标准的差距分析并采取必要的纠正预防措施。接受内外部审计的工作。

Support the new Project, eg. Product launch related QC work（10%）

服务于新的项目，例如产品上市相关的质量控制内容。

REQUIREMENTS

A degree in Chemistry, Pharmacy and Biology or other related disciplines and a minimum of 4 years experience in analytical methodologies as HPLC, GC, TLC, etc.

化学、药学和生物或相关专业学士学位，至少4年以上分析工作经验，会使用HPLC、GC、TLC等分析仪器。

Must be problem solving oriented. Good English writing and spoken as well as a good knowledge of Chinese and international GMP are required.

须具备善于解决问题的能力和主动性。英语说、写良好。要求了解中国和国际GMP要求。

在如下领导力方面具有较为成熟的能力

1. Sets clear direction & aligns team & others around common objectives

设定明确的方向，与团队一起为共同的目标达成一致

2. Energizes the team 激励团队

3. Display passion 展现激情

4. Exercises good judgment & drives change for competitive advantage运用良好的判断力，推动变革

5. Drives for superior results & has passion to win

追求卓越，有赢的热情

6. Builds the talent pipeline and develop others 搭建人才发展梯队发展团队

7. Inspires continuous improvement & breakthrough thinking,display analytical &conceptual thinking.

鼓励持续性改进和突破性思维，展示分析性和概念性思维能力

8. Good communication

良好的沟通能力

9.Able to burden pressure, result driven

能够耐受压力，结果导向。

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.