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QA Engineer

beigene · 广州市, 广东, 中国

External listingfull-time2 months ago

About The Role

  • Responsible for drafting and maintain the risk assessment of QA on-site supervision. 负责起草和维护QA现场监控风险评估。 • On-site quality management of Drug Substance, to ensure that the production activities and on-site management could meet regulations and BeiGene’s requirements. 负责原液生产工序生产的现场质量管理，确保生产活动及现场管理符合GMP和法规要求。 • Responsible for validation protocol and report review, validation deviation report review. 负责验证方案及报告的审核，负责验证偏差报告的审核。 • Ensure timely reporting of quality event, support the investigations and risk assessment. 确保及时向上汇报质量事件，协助质量事件的调查及风险评估。 • Supervise of the implementation of Data Integrity policy and provide related knowledge to Production. 监督数据可靠性政策的执行，向生产部门提供相关的知识。 • Responsible for production batch record review. 负责批生产记录关键质量控制点的审核。 • Responsible for audit trail review. 负责审计追踪审核。 • Supervise the implementation of rejected products disposal procedure. 监督不合格品的处理情况。 • Support response and investigation of internal and external audit, ensure audit findings are fully investigated and CAPAs are reasonable and sufficient. 支持内外部审计应答及审计发现项的调查，审核整改报告，确保发现项得到充分调查并制定合理的纠正预防措施。 • Responsible for quality system documents and CMC documents review. 负责体系文件及CMC文件的审核。 • As POC of Quality Assurance, responsible for project quality management, cross-department communication, project quality risk management, quality procedure control, change control assessment and any abnormal follow up. 作为质量保证部门的代表，负责项目质量管理，执行相关的跨部门沟通、项目质量风险管理、质量流程控制、变更评估及异常跟进。 • 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，即使汇报EHS相关事故及隐患。 • 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’s or above degree in Pharmaceutical, Chemical, Biology, Microbiological or related field. 药学，化学，生物学、微生物学或相关学科学士或以上学位 Technical/Skills Required 技术/技能需求 Ÿ Have the ability to apply the information/knowledge with expanded principles, approaches, techniques and patterns to new specific scenarios, in order to develop rational solutions or make the right decisions, including, 能将以下信息/知识用于新的具体情境，包括对其原则、方法、技巧及规律的拓展，从而利用拓展的信息/知识提供合理的解决方案或做出正确的决策。包括：  NMPA GMP, EU GMP, PIC/S GMP and FDA cGMP 中国GMP，欧盟GMP，PIC/S GMP及美国GMP  On-site quality management procedure 现场质量管理流程  Batch record review requirements 批记录审核要求  Deviation and OOX investigation principle. 偏差及超标/超趋势调查原理  Knowledge of Visual Inspection 人工灯检知识  Biological products key quality control points 生物制品关键质量控制点  Combination product key quality control points 组合产品关键质量控制点 Ÿ Understand the meaning and intension of specified information/knowledge with the ability to communicate and execute in the following manner, including, 能理解以下信息/知识的内涵和意义，并正确传达和执行。包括：  Drug management regulation/Manufacturing management regulation 药品管理法/生产监督管理办法等法规  Registration management regulation and so on 注册管理办法以及相关法规  Audit trail review requirements 审计追踪审核要求  Quality risk management process and tools. 质量风险管理工具  Knowledge of HVAC system and process water operation and monitoring 空调系统及工艺用水系统运行及监控的基本知识  Change Control management process and have the ability to conduct change evaluation on behalf of quality assurance 变更管理流程并具备代表质量保证进行变更评估的能力  Knowledge of phase-appropriate quality system 阶段性质量管理体系  Knowledge of tech transfer process 技术转移知识  Manufacturing Process basic knowledge 生产工艺基本知识 Ÿ Strongly address, investigate and solve ability 具有较强的处理，分析和解决问题的能力 Ÿ Strong communication, presentation and decision-making skills 具有较强的沟通、表达及决策能力 Working Experience 工作经验  At least 5 years relevant experience in quality assurance or manufacturing or process improvement in pharmaceutical manufacturing enterprises with bachelor’s degree, or 本科学历，至少5年药品生产企业质量保证或生产、工艺改进的工作经验，或  At least 3 years relevant experience in quality assurance or manufacturing or process improvement in pharmaceutical manufacturing enterprises with master’s degree, or 硕士学历，至少3年药品生产企业质量保证或生产、工艺改进的工作经验，或  No work experience but Doctoral degree 无工作经验，博士学历 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 Ÿ Master office software, including but not limited to Word, Excel, PPT and Visio or equivalent tools; 掌握办公软件，包括但不限于Word, Excel, PPT及Visio或同等功能软件； Ÿ Ability to Read English regulations, guidelines and documents related to job responsibilities, write English emails and standard operating procedures. Ÿ 掌握工作职责相关的英文法规、指南及文件的阅读，英文邮件及标准操作规程的撰写。 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.

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