Senior Physicochemical Analyst-Product Test

• Ensure to keep abreast of laws and regulations, draft and update related management regulations, quality standards, operating regulations, WI, forms and records of physical and chemical laboratories to ensure compliance with laws and regulations. 确保及时了解法规动向，起草和更新理化实验室相关的管理规程文件、质量标准文件、操作规程文件、WI及表格、记录等，确保其符合法规要求。

• Responsible for the investigation of AE/OOS/OOT/Non-long Term Study related to physical and chemical laboratory, and complete the investigation report. Responsible for the daily management of , Monitor abnormal event registration, complete periodic review and analysis of abnormal events, archive and maintain all investigation record. 协助理化实验室相关AE/OOS/OOT/OOE/非长期试验的调查过程。负责《实验室检验过程异常事件处理台账》的日常管理，监督异常事件登记，完成异常事件周期性回顾及分析，归档、保管AE调查记录。

• Participate in the validation, transfer and

of test methods for newly introduced clinical products, and perform method optimization if necessary. 参与新引入临床产品的测试方法的验证、转移及确认，必要时进行方法优化等工作。

• Responsible for the inspection of samples in accordance with quality standards and procedures and the follow-up of the final report of samples. Responsible for the related work of the contract laboratory, such as the provision of samples, test methods and standards;

• 负责根据质量标准和程序执行生产过程样品的检验以及样品最终报告的报告跟踪，负责合同实验室的相关工作，比如样品、检验方法、标准的提供等；

• Responsible for the inspection of samples in accordance with quality standards and procedures and the follow-up of the final report of samples. Responsible for the related work of the contract laboratory, such as the provision of samples, test methods and standards; 负责根据质量标准和程序执行生产过程样品的检验以及样品最终报告的报告跟踪，负责合同实验室的相关工作，比如样品、检验方法、标准的提供等；

• Responsible for laboratory 6S maintenance and finishing. 负责实验室6S维护整理。

• Responsible for setting the OOT limit for QC products and completing the OOT limit report. 负责QC产品相关OOT限度的制定，并完成OOT限度报告。

• Responsible for change control and deviation initiation related to physicochemical lab, and evaluation/investigation, CA/CAPA implementation and other related work. 负责理化相关变更、偏差的发起、评估/调查、相关CA/CAPA的执行等相关工作。

• Assist to complete the audit related work, and complete the corresponding corrective measures for the audit findings. 协助完成审计相关工作，针对审计发现项完成相应整改措施。

• Follow the company EHS policy and procedure; fulfill responsibility of EHS related regulation, timely report EHS accident and risk. 遵守公司各项EHS规章制度；履行EHS相关 法规责任，及时汇报EHS相关的事故及隐患。

• Any other assignment as is determined by supervisor. 完成上级安排的其他工作。

• Follow the company EHS policy and procedure; fulfill responsibility of EHS related regulation, timely report EHS accident and risk. 遵守公司各项EHS规章制度；履行EHS相关 法规责任，及时汇报EHS相关的事故及隐患。

• Any other assignment as is determined by supervisor. 完成上级安排的其他工作。 Education/ Professional Qualification 学历/专业资格 Bachelor degree or above in pharmacy, biology or chemistry； 本科或以上学历，药学，生物学或化学专业； 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 drug testing knowledge, laboratory safety knowledge, familiar with the application of physical and chemical testing, instrument analysis; 熟悉药品检验知识、实验室安全知识，熟悉、应用理化检验、仪器分析； Familiar with handling the laboratory abnormal event and deviation 熟悉实验室异常事件及偏差的处理流程 Good communication and coordination skills. 具有良好的沟通协调能力； Working Experience 工作经验 At least 5 years experience in pharmaceutical analysis; 至少5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 Have good communication, organization and coordination, problem-solving skills, and strong written and oral expression skills. 有良好的沟通、组织协调、问题解决能力，有较强的书面、口头表达能力。 Have good English listening, speaking, reading and writing skills. 具有良好的英文听说读写水平。 Familiar with the use of office software. 熟悉常用办公软件的使用。 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 BeOne Global Competencies When we exhibit our values of Patients First, 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 求职者隐私申明： 百济神州致力于尊重和保护您的个人信息权利，并承诺依据合法、正当、必要和诚信的原则处理您的个人信息（包括个人敏感信息 ）。 由于百济神州在全球范围内开展业务，我们可能需要基于人力资源管理等合理业务目的而将您的个人信息发送和/或存储在位于您所在国家以外其他国家（例如：美国）的服务器和数据库中，详情参见百济神州《求职者隐私政策》（百济神州官网 - 隐私政策 - 求职者隐私政策）。 如您主动向我们提供您的简历信息或其他个人信息，则视为您已经充分理解并确认接受百济神州《求职者隐私政策》内容。如您对此有任何疑问的，请勿提交简历信息或其他个人信息。 BeOne is committed to respect and protect your personal information rights, and will process your personal information, including your sensitive personal information, based on the principles of legality, legitimacy, necessity, and integrity. Due to the reasonable business need for human resource management as a result of BeOne’s global operation, your personal information may be transferred and/ or stored in a server/database located in a third country (e.g., the United States) other than your own country. For further details, please refer to BeOne Job Applicant Privacy Policy (BeOne official website - Privacy Policy - Job Applicant Privacy Policy). If you voluntarily provide your resume or other personal information to us, it is deemed as you have thoroughly acknowledged and accepted BeOne Job Applicant Privacy Policy. If you have any concern, please DO NOT submit your resume or any other personal information.