Senior SpecialistAssociate manager, Manufacturing Support
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Job Location:
Monthly Salary:
Posted on:
9 hours ago
Vacancies:
1 Vacancy
Job Summary
责任描述和工作范围
运营管理
- 按计划完成生产所需要的管路器具组装灭菌溶液配置等生产任务
- 配合生产完成样品递送补料申请等操作
- 负责部门内清洁外包服务人员的管理包括人员招聘培训KPI考核和工作安排等
- 负责生产部门清洁消毒人员行为更衣的管理工作起草更新相关SOP文件及时对发现的问题进行跟踪处理
- 负责生产外包清洗服务公司的对接和管理工作
- 负责生产部门废弃物的灭活和处置
- 负责生产内部非GMP物料的统计和采购申请和管理工作
- 负责生产部门储存间的管理工作
- 参与风险评估变更偏差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
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本科及以上学历
- 5年以上溶液配制无菌操作及相关GMP生产环境工作经验
- 具备丰富的GMP工作经验有商业化生产经验的优先
- 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
- 具备基础英语读写能力能理解相关技术文件
- 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
