Specialist I&II, Manufacturing-Lean
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Job Location:
Monthly Salary:
Posted on:
6 hours ago
Vacancies:
1 Vacancy
Job Summary
责任描述和工作范围
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
01-Feb-2026Closing Date
30-May-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:
IC
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
