理化分析师 (MJ017057)

Act as SMEs for the method optimization and/or troubleshooting of related methods and/or instruments; provide technical support to QC operation.

作为SME;对相关方法和/或仪器进行方法优化和/或故障排除;为质量控制操作提供技术支持。

Ensure to keep abreast of laws and regulations. Draft and update related management regulations, quality standards, operating procedures, work instructions, laboratory records to ensure compliance with laws and regulations;

确保及时了解法律法规。起草和更新相关管理规定、质量标准、操作规程、工作说明、实验室记录;以确保符合法律法规;

Participate in gap analysis of the relevant 02regulations, ensure the method validation compliance with regulations for PPQ and BLA filing.

参与相关法规的差距分析;确保方法验证符合PPQ和BLA备案的规定。

Responsible for the establishment and management of product quality acceptance criteria.02

负责产品质量标准的建立和维护;02

Responsible for related change control, deviation, evaluation/investigation, and CA/CAPA .

负责相关变更、偏差的发起、评估/调查、相关CA/CAPA的执行等相关工作。

Follow the company EHS policy.

遵守公司各项EHS规章制度。

Complete other assignments from the supervisor.

完成上级安排的其他工作。

02

Education/ Professional Qualification

学历/专业资格

Bachelor degree or above in pharmaceutical sciences, biology, chemistry, or other related fields;

本科或以上学历;药学;生物学, 化学专业或其他相关专业;

Technical/Skills Required

技术/技能需求

Familiar with Chinese pharmacopoeia, American pharmacopoeia, European pharmacopoeia and GMP/cGMP/ Europe GMP requirements;

熟悉中国药典、美国药典、欧洲药典及GMP/cGMP/欧盟GMP的相关要求;

Familiar with analytical technology of biological products, laboratory safety knowledge, familiar with the application of HPLC/UHPLC, GC and CE devices, and other routine laboratory instruments;

熟悉生物药产品分析技术、实验室安全知识;熟悉HPLC/UHPLC, GC 和CE仪器;及其他常规实验室仪器的使用;

Familiar with general physiochemical test methods, e.g. color, charity, pH, osmolality, sub-visible particles, visible particles, etc.

熟悉一般理化检测方法;例如颜色;澄清度;pH;渗透压;不溶性微粒和可见异物等;

Familiar with method validation practice of LC, CE, GC, and other general methods for biological products;

熟悉生物药产品相关LC;GC和CE等理化方法和其他生物药产品一般理化方法相关方法学验证规程;

Good communication and coordination skills.

具有良好的沟通协调能力;

Working Experience

工作经验02

At least 3 years’ experience in pharmaceutical analysis;

医药行业3年以上药物分析工作经验;

Language, Computer Literacy, Office Software, etc.

语言能力;电脑知识;办公软件等

Good command of English and computer skills;

英语水平良好;会熟练使用电脑;

Others

其他02

Familiar with the operation of Empower software;

熟练掌握Empower软件的操作;

02

百济神州全球胜任力

当我们通过以下十二项全球胜任力，展现出 "患者为先"、"无界协作"、"锐意创新 "和 "追求卓越 "的价值观时，我们就能帮助全世界更多患者获得更多负担得起的药品。

●团队协作

●提供并征求坦诚及可行的反馈

●自我认知

●兼容并蓄

●积极主动

●开拓精神

●持续学习

●拥抱变化

●结果导向

●分析性思维/数据分析

●卓越财务

●清晰沟通

BeiGene Global Competencies

When we exhibit our values of Patients ***, Collaborative Spirit, Bold Ingenuity and Driving Excellence, through our twelve global competencies below, we help get more affordable medicines to more patients around the world.

●Fosters Teamwork

●Provides and Solicits Honest and Actionable Feedback

●Self-Awareness

●Acts Inclusively

●Demonstrates Initiative

●Entrepreneurial Mindset

●Continuous Learning

●Embraces Change

●Results-Oriented

●Analytical Thinking/Data Analysis

●Financial Excellence

●Communicates with Clarity

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If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeiGene Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.