QC Specialist

General Description: Reporting to the Beijing site QC Lead, executes analytical tests as assigned tasks. In this role, participate GMP QC related activities which are contributing to business objectives. This individual must have a basic understanding of GMP, internal guidance, Data Integrity principle and the routine lab processes, an in-depth understanding of analytical technologies. 执行指定的分析检测任务,向北京公司质量控制负责人汇报。此角色将参与有助于实现业务目标的GMP 质量控制相关活动。对GMP、国际指导原则、数据可靠性原则和常规实验室流程有基本了解,对分析技术有深入的了解。 Essential Functions of the job: 1. Operate the common analytical equipment independently, such as HPLC, UV-Vis, IR, KF, Dissolution etc. 独立操作常用的分析设备,比如高效液相、紫外、红外、水分仪、溶出仪等。 2. Conduct routine monitoring of purified water system, clean room air system and cleaning verification, of production equipment. 对纯化水系统、洁净室空调系统进行日常监控,执行生产设备的清洁确认。 3. Perform sampling and complete tests for in-coming materials (API, excipient, pack component). 对来料(原料,辅料,包装材料)执行取样和检测。 4. Finish release tests for GMP clinical batches and stability tests per stability protocol. 完成GMP临床批次的放行检测并参照稳定性方案完成稳定性检测。 5. Conduct method validation activities per method validation/transfer protocol. 根据方法验证/转移方案完成方法验证活动。 6. Complete test records per Good Documentation Practice. 按照良好记录规范要求完成检测记录。 7. Understanding QC SOP/SPEC, review and update SOP/SPEC as required. 理解质量控制相关的操作规程和质量标准,根据需要审核和更新操作规程和质量标准。 8. Participate qualification, calibration and maintenance of the analytical equipment. 参与分析仪器的确认、校准和维护。 9. Manage reference standards and stability samples. 管理标准品和稳定性样品。 10. Accomplish the required initial and continuing training for quality personnel. 完成质量人员必需的入职培训和更新性培训。 11. Draft stability report or other technical reports. 起草稳定性报告或其他技术报告。 12. Contact contract vendor for samples, external testing and the relevant data pack. 就样品、外部检测和相关数据包联系合同供应商。 13. Other duties as assigned by superior. 上级交予的其它工作。 Education Required: Master degree, Major in pharmacy, analytical chemistry or related 硕士学历，药学、分析化学或相关专业 Experience： 1-2 year QC related working experience 1-2年QC相关工作经验 Computer Skills: Proficient in computer skills including Outlook, Word, Excel, and PowerPoint, etc. 熟练掌握计算机技能,包括操作Outlook,Word,Excel,and PowerPoint等办公软件。 Other Qualifications: Capability of arranging and completing tasks per priority 具备按优先级别安排和完成任务的能力 Ability to communicate well within and across teams 具备良好的团队沟通和跨部门沟通能力 English: fluent in writing and speaking 英语水平:口语和书面表达流利 Travel: Travel is required if necessary 必要时需要出差 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.