BeiGene continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer.
Job Description:
负责BIO QC临床阶段新项目的管理,负责BIO QC实验室设备全生命周期的管理，统筹设备验证、维护等工作；实验室试剂、耗材管理，实验室5S管理；样品（常规、稳定性、留样）、对照品管理；检验记录管理；BIO QC数据维护；检验数据统计，出具COA。 Responsible for the management of BIO QC new clinical projects.Responsible for managing the entire lifecycle of BIO QC lab equipment, coordinating equipment verification, maintenance. Management of laboratory reagents and consumables; laboratory 5S management.Sample (routine, stability, retention) management; Inspection Record Management. QC data maintenance；Inspection data statistics, issuance of COA.
1. 负责BIO QC临床阶段新项目的管理； Responsible for the management of new clinical projects.
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2. 负责BIO QC lab 设备全生命周期的管理，统筹设备验证、维护等工作； Responsible for managing the entire lifecycle of BIO QC lab equipment, coordinating equipment verification, maintenance, and other work.
3. 实验室试剂、耗材管理，实验室5S管理； Management of laboratory reagents and consumables; laboratory 5S management.
4. 样品（常规、稳定性、留样）、对照品管理；检验记录管理； Sample (routine, stability, retention) management; Inspection Record Management.
5. BIO QC数据维护；检验数据统计，出具COA； BIO QC data maintenance；Inspection data statistics, issuance of COA.
6. 协助上级参与新厂区实验室的建设； Responsible for assisting superiors in participating in the construction of the new factory laboratory.
7. 协助BIO QC实验室的管理，流程的优化； Assist in management of QC lab and optimizing the BIO QC process.
8. 负责BIO QC实验室的安全工作； Responsible for the safety work of the BIO QC laboratory.
9. 负责协助公司内部审计和应对外部审计； Responsible for assisting the company's internal audit and responding to external audits.
10. 完成上级指派的其他任务、项目工作。 Complete other tasks and project work assigned by superiors.
Qualification Required:
工作要求： 本科及以上学历，药学、生物学相关专业; Bachelor's degree or above, major in pharmacy or biology. 熟悉QC检验设备及计量、验证要求； Familiar with QC inspection equipment and measurement and verification requirements. 熟悉GMP，QC管理流程; Familiar with GMP and QC management processes. 5年医药工作经历； With at least 5 years of pharmaceutical work experience. 擅长生物药产品的日常QC检测，以及相应的规范化操作; Proficient in daily QC testing of biopharmaceutical products and corresponding standardized operations. 有参与过QC lab 0-1建设经验； Have experience in QC lab 0-1 construction 英语读写能力熟练； Fulent English read and written capability. 具备较强的执行力、良好的团队领导和协作能力； Possess strong execution ability, good team leadership and collaboration skills. 有较强沟通能力，分析和解决问题能力; Strong communication skills, analytical and problem-solving skills. 有较强责任心，耐心细致； Have a strong sense of responsibility, patient and meticulous.
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