AS&T 分析师

工作目的： 按照GMP及SOP的要求开展工作 Execute the work according to GMP and SOPs 主要职责： 1. 负责本岗位相关文件的起草和审核。 Create and review documents related to this job. 2. 日常工作符合EHS要求。 Routine activity meets EHS requirements. 3. 通过培训后，根据相关的SOP完成相应支持性工作。 After training, complete the support work according to the relevant SOP. 4. 必要时参与实验室事件调查活动并提供相关技术支持。 Carry out the lab event investigation and provide the technical support as required. 5. 负责QC实验室仪器的维护和维修。 Be responsible for the maintenance and repair of instruments in QC lab. 6. 负责产品中控检测、生产设备清洁确认、放行和稳定性检测。 Be responsible for drug product IP test, manufacture equipment cleaning residue test, release and stability test. 7. 负责分析方法验证/确认/转移，包括方案和报告的起草和执行。 Be responsible for method validation/verification/transfer including the draft and execution of protoocland report. 8. 严格执行实验和实验结果记录。 Conduct testing as required, and document the tests and results in the associated system. 9. 负责实验记录的复核，包括审计追踪。 Responsible for reviewing test records and conducting audit trails. 10. 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. 11. 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. 12. 其他管理层安排的任务。 Other work from lab management. 学历要求： 本科及以上学历，药学，生物学或化学专业 Bachelor or above degree in Pharmacy, Biology, Chemistry, etc. 技术技能： 1.专业技能 Professional technical skills 熟练QC实验室管理和基本操作，熟悉天平、pH计、HPLC、溶出仪等仪器的操作和工作原理。 Familiar with the management and operation in QC lab, familiar with the operation and working principle of electronic balance, pH meter, HPLC, dissolution tester and etc.. 熟悉方法验证、新药申报等相关法规、药典、ICH等要求，并运用到日常工作中。 Familiar with requirements of method validation and NDA filing in related regulation, pharmacopiea and ICH and can meet the requirements in work. 2.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. 3.沟通能力Communication Capability 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. 4.项目管理能力 Project Management Capability 具备一定的项目管理能力和数据趋势分析的能力。 Have some ability of project management and trend analysis of data. 工作经验： 5年以上QC实验室或研发分析实验室工作经验。 More than five years' experience in QC lab or analytical research lab. 语言和电脑知识： 英语水平良好，能独立使用英文读写文件，熟练使用电脑 Good English, have the ability to read and write documents in English and good computer skill 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.