Associate AST Project Manage

Associate AST Project Manage 发布于 2026-09-07 MJ022991 MJ022991 | GZ Quality Assurance GZ Quality Assurance | 全职 全职 | 广东·广州市 广东·广州市 Roles/Responsibilities职责•    Manage or participate the project management on the QC related new product technology transfers;负责和参与QC实验室相关的新产品技术转移的项目管理工作；•    Lead and manage the QC operational excellence projects and continuously monitor and optimize QC process;  领导和管理QC卓越运营项目并持续对QC的业务流程进行监控和优化；•    Proactively interact and communicate with cross functional teams in and out of QC to accurately deliver the information and collect the feedback on the QC operation in time;积极与QC内外的跨部门进行交流和沟通， 及时为QC的运作传达准确的信息以及搜集相关的反馈；•    Responsible for QC related test method transfer, project management and HA audit support for new market submission; 负责新市场申报QC相关的分析方法转移和项目管理工作并支持官方审计•    Lead phase appropriate QC procedure optimization to fit business needs based on multiple region regulations including China/US/EU, establish and update related laboratory management procedures to keep abreast of laws and regulations;根据中美欧多国法规要求和公司业务需求，优化阶段性QC管理规程，制定和升版实验室管理文件，确保符合法规要求•    Support and assist AST head on QC-AST department management;支持和协助AST负责人对QC-AST部门进行管理；•    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。Job Requirements工作要求Education/ Professional Qualification学历/专业资格Master or above degree in Pharmaceutical Engineering, Bioengineering, IT& Computer Engineering, Automation engineering or related fields.硕士或以上学历，制药工程、生物工程，信息管理与计算机工程，自动化工程等相关专业Technical/Skills Required技术/技能需求Capable for project management, including stakeholders, resources, scheduling, risk and change control; 具有项目管理的能力，包括利益相关方、资源、计划、风险和变革的控制；Understand the operation and the major analytical methods of large molecule drugs QC lab;了解大分子药品QC实验室的运作方式和主要的检测方法；Familiar with operational excellence and its application in a quality system; 熟悉卓越运营理念以及在质量体系中的应用；Good communication and coordination ability;具有良好的沟通协调能力；Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry;具有生物制药行业质量控制，良好规范和相关标准的专业知识；Familiar with the ChP/USP/EP and the cGMP/EU GMP;熟悉中国药典、美国药典、欧洲药典及cGMP/欧盟GMP的相关要求；Working Experience工作经验 •    3 years and more working experience in pharmaceutical analysis, large molecule experience preferred;医药行业3年以上药物分析工作经验, 有大分子经验者优先；•    1 year and more project management experience, with operational excellence project experience preferred.项目管理经验1年以上，有卓越运营项目经验者优先。Language, Computer Literacy, Office Software, etc.语言能力，电脑知识，办公软件等•    Fluent with English and Chinese in both oral and written communication.具有流利的英语和中文口语和书面沟通能力。•    Familiar with Microsoft Office software and common statistical software (e.g.Minitab, JMP).熟悉微软办公软件和常见的统计软件（如Minitab, JMP） 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 an

y other personal information. Roles/Responsibilities 职责 •    Manage or participate the project management on the QC related new product technology transfers; 负责和参与QC实验室相关的新产品技术转移的项目管理工作； •    Lead and manage the QC operational excellence projects and continuously monitor and optimize QC process; 领导和管理QC卓越运营项目并持续对QC的业务流程进行监控和优化； •    Proactively interact and communicate with cross functional teams in and out of QC to accurately deliver the information and collect the feedback on the QC operation in time; 积极与QC内外的跨部门进行交流和沟通， 及时为QC的运作传达准确的信息以及搜集相关的反馈； •    Responsible for QC related test method transfer, project management and HA audit support for new market submission; 负责新市场申报QC相关的分析方法转移和项目管理工作并支持官方审计 •    Lead phase appropriate QC procedure optimization to fit business needs based on multiple region regulations including China/US/EU, establish and update related laboratory management procedures to keep abreast of laws and regulations; 根据中美欧多国法规要求和公司业务需求，优化阶段性QC管理规程，制定和升版实验室管理文件，确保符合法规要求 •    Support and assist AST head on QC-AST department management; 支持和协助AST负责人对QC-AST部门进行管理； •    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。 Job Requirements 工作要求 Education/ Professional Qualification 学历/专业资格 Master or above degree in Pharmaceutical Engineering, Bioengineering, IT& Computer Engineering, Automation engineering or related fields. 硕士或以上学历，制药工程、生物工程，信息管理与计算机工程，自动化工程等相关专业 Technical/Skills Required 技术/技能需求 Capable for project management, including stakeholders, resources, scheduling, risk and change control; 具有项目管理的能力，包括利益相关方、资源、计划、风险和变革的控制； Understand the operation and the major analytical methods of large molecule drugs QC lab; 了解大分子药品QC实验室的运作方式和主要的检测方法； Familiar with operational excellence and its application in a quality system; 熟悉卓越运营理念以及在质量体系中的应用； Good communication and coordination ability; 具有良好的沟通协调能力； Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry; 具有生物制药行业质量控制，良好规范和相关标准的专业知识； Familiar with the ChP/USP/EP and the cGMP/EU GMP; 熟悉中国药典、美国药典、欧洲药典及cGMP/欧盟GMP的相关要求； Working Experience 工作经验 •    3 years and more working experience in pharmaceutical analysis, large molecule experience preferred; 医药行业3年以上药物分析工作经验, 有大分子经验者优先； •    1 year and more project management experience, with operational excellence project experience preferred. 项目管理经验1年以上，有卓越运营项目经验者优先。 Language, Computer Literacy, Office Software, etc. 语言能力，电脑知识，办公软件等 •    Fluent with English and Chinese in both oral and written communication. 具有流利的英语和中文口语和书面沟通能力。 •    Familiar with Microsoft Office software and common statistical software (e.g.Minitab, JMP). 熟悉微软办公软件和常见的统计软件（如Minitab, JMP） 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. 立即投递