运营管理 负责部门内偏差调查和变更控制工作以及偏差、CAPA有效性的分析与回顾，推动持续改进； 负责部门风险评估活动，法规差距分析，推动合规体系建设，持续识别生产过程中的GMP符合性与操作风险。 进行工艺流程和数据分析，推动生产流程优化与标准化，持续提升生产效率与质量； 起草、定期回顾、优化生产部门工艺和管理类文件； 支持准备内、外部门审计工作，包含准备审计资料，陪同审计老师或参观人员，跟踪整改跟进。 负责部门SHE巡检工作，及时对发现的问题进行跟踪处理； 负责生产内部项目管理工作，参与并推动跨部门协作优化项目工作。 必要时，参与生产活动。 培训 负责部门员工资质的管理工作； 完成个人培训计划，并通过考核； 负责或参与对他人进行管理流程、GMP合规要求等培训。 其他 支持生产部门合同事务，包括采购项目URS编写、合同签订及持续性付款申请等； 遵守《药品生产质量管理规范（2010版）》、《药品记录与数据管理要求（试行）》以及公司数据完整性管理等相关规定； 完成领导交办的其他任务。 任职资格 细胞生物学、分子生物、统计学等相关专业211本科及以上学历； 至少3年以上细胞培养、无菌操作及相关GMP环境的生产或QA工作经验； 具备较强的GMP药物生产理念； 具备偏差调查、CAPA、变更控制等质量管理工具的实际经验； 具备良好的文档撰写能力 能独立起草SOP、批记录等文件； 具备良好的英语听说读写能力； 具备团队协作精神、沟通能力及问题解决能力。 Date Posted 05-Aug-2026 Closing Date 29-Aug-2026 AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements. AstraZeneca is a global, science-led, patient-focused biopharmaceutical company. We focus on discovering, developing and commercialising prescription medicines for some of the world’s most serious diseases. But we are more than one of the world’s leading pharmaceutical companies. At AstraZeneca, we’re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science, challenge convention and unleash your entrepreneurial spirit. To embrace differences and take bold actions to drive the change needed to meet global healthcare and sustainability challenges. There is no better place to make a difference in medicine, patients, and society. An inclusive culture where you will connect different thinking to generate new and valuable opportunities. Where you will find a commitment to lifelong learning, growth and development for all. Our Inclusion & Diversity (I&D) mission is to create an inclusive and equitable environment where people belong, using the power of our diversity to push the boundaries of science to deliver life-changing medicines to patients. Inclusion and diversity are fundamental to the success of our company, because innovation requires breakthrough ideas that only come from a diverse workforce empowered to challenge conventional thinking. We’re curious about science and the advancement of knowledge. We find creative ways to approach new challenges. We’re driven to make the right choices and be accountable for our actions. As an organisation centred around what makes us human, we put a big focus on people. Across our business, we want colleagues to wake up excited about their day at the office, in the field, or in the lab. Along with our purpose to bring life-changing medicines to people across the globe, we have a promise to you: to help you realise the full breadth of your potential. Here, you’ll do work that has the potential to change your life and improve countless others. And, together with your team, you’ll shape a culture that unites and inspires us every day. This is your life at AstraZeneca.