Associate Manager, Manufacturing
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Job Location:
Monthly Salary:
Posted on:
Yesterday
Vacancies:
1 Vacancy
Job Summary
责任描述和工作范围
生产执行与操作
- 执行细胞培养转导纯化制剂冻存等核心操作按计划完成细胞产品生产任务
- 执行溶液配制管路组装清洗灭菌设备设施操作与日常清洁维护等工作
运营管理
- 制定生产计划调度生产人员按计划完成工作
- 负责部门人员招聘人才培养和团队建设KPI制定和考核制定部门预算
- 负责生产车间设备工具清洁消毒现场5SSHE等工作确保生产活动现场环境符合GMP要求
- 负责组织配合生产工艺设备工具的计量验证等活动
- 负责组织生产部门接收新项目生产工艺搭建生产平台完成项目落地
- 负责生产工艺转出项目中生产职责部分
- 参与风险评估变更偏差文件规程的起草审核等活动识别生产过程中的GMP符合性与操作风险配合生产精益合规部落实相关CAPA持续提升生产工作效率与质量
- 完成领导交办的其他任务
- 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
现场监督与审计支持
- 负责生产内部车间巡检跟踪确认巡检问题
- 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
培训
- 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
任职资格
- 细胞生物学分子生物学等相关专业211本科及以上学历
- 至少6年以上细胞培养无菌操作及相关GMP生产环境工作经验
- 具备丰富的GMP药物生产理念并能够指导实际应用
- 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 具备较强的责任感和抗压能力
- 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
07-Jan-2026Closing Date
29-Apr-2026AstraZeneca 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.
Required Experience:
Manager
Key Skills
- Lean Manufacturing
- Six Sigma
- Continuous Improvement
- ISO 9001
- Lean Six Sigma
- Management Experience
- Manufacturing & Controls
- 5S
- Manufacturing Management
- Kaizen
- Chemistry
- Manufacturing
About Company
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, ... View more
