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.
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Job Description:
不断改进提高QC工作流程，协助管理层不断提高QC的工作质量。
Continually optimize QC work stream and support QC management team to continually improve QC work quality.
确保QC的活动符合GMP，GLP和其它法规要求
Ensure the compliance of QC activities with GMP, GLP, and other regulatory requirements.
1.负责对照品中心事宜，包括的对照品的计划、接收、分装、标定、全球供应、分放、跟踪等，同时优化对照品管理体系。
Responsible for the Reference Center, including planning, receiving, packaging, standardization, global supply, distribution, tracking, and optimizing the reference management system.
2.负责实验室培训管理，包括培训体系的建立和优化、培训矩阵优化、培训师资质需求的建立和阶段性强化、新老员工培训包的创建和维护、操作技能的培训计划和执行跟踪、质量事件后续培训的有效性跟踪等。
Responsible for laboratory training management, including the establishment and optimization of training systems, optimization of training matrices, establishment and phased strengthening of trainer qualification requirements, creation and maintenance of training packages for new and old employees, training plans and execution tracking of operational skills, and effectiveness tracking of subsequent quality event training.
3.负责协助完成新工厂实验室建设工作，包括新厂分析方法转移、文件体系建立和优化、仪器验证等
Responsible for assisting in the construction of the new site laboratory, including the transfer of analytical methods, establishment and optimization of document systems, instrument verification and so on
4.负责实验室5S工作和日常GEMBA检查，跟踪日常整改项的执行，协助实验室管理层和QA共同提高实验室现场管理。
Responsible for 5S work and daily GEMBA inspections in the laboratory, tracking the implementation of daily rectification items, and assisting the laboratory management and QA in jointly improving laboratory on-site management
5.负责实验室Smart QC相关事宜，包括项目推进和优化，后期静态数据维护和实验室Admin管理，以及后期Smart QC数据分析，支持实验室人力资源统筹管理。
Responsible for Smart QC related work in the laboratory, including project promotion and optimization, static data maintenance and laboratory Admin management in the later stage, as well as Smart QC data analysis in the later stage for supporting the overall management of laboratory human resources
6.承担个人安全职责，保护自己，并避免伤害他人和环境。参加该岗位的必须的安全培训并配合应急预案的演练。
Take personal safety responsibility, protect yourself and avoid hurting others and the environment. Participate in the necessary safety training for the post and cooperate with the drill of emergency plan.
7.严格执行岗位安全操作规程。及时汇报工作中的任何事故事件和危险源。
Strictly follow EHS procedure. Report any EHS accident and hazard in a timely manner.
8.其他管理层安排的任务
Other work from lab management
Qualification Required:
本科或以上学历，药学，生物学或化学专业等
Bachelor or above degree in Pharmacy, Biology, Chemistry, etc.
制药或相关行业5年以上分析工作经验
5 years or more work experience on analysis in pharmaceutical industry or associated industries
- 专业知识能力Professional knowledge and competence
熟悉口服制剂的检验，熟悉GMP/GLP的相关要求。
Familiar with testing of oral products, familiar with GMP/GLP requirements.
学习能力Learning ability
持续的学习能力获得新的知识或技巧以胜任工作的要求。
Continuously invest time and effort to gain new skills and knowledge required to succeed in the work.
沟通能力Communication capabilities
团队内部和外部的人员进行积极有效的沟通。
Show strong willingness to work closely with peers within and outside the team toward a common goal.
组织能力Organization capabilities
准确理解实验室具体的项目内容， 组织相关人员进行有效沟通，聆听团队成员的不同声音并达成一致，确定清晰的执行方案，如需，建立或优化实验管理体系。
Accurately understand the specific project content of the laboratory, organize relevant personnel to communicate effectively, listen to the different voices of team members and reach an agreement, determine a clear implementation plan, if necessary, establish or optimize the experiment management system.
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