Specialist I&ii, Manufacturing Support

AstraZeneca 苏州, 江苏, CN

Published 2026-02-18

Description

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;
管理外包员工,配合生产完成样品递送等工作;
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;
生产外包清洗服务公司的对接和管理工作;
生产部门废弃物的灭活和处置;
生产内部非GMP物料的统计和采购申请和管理工作;
生产部门储存间的管理工作;
支持相关设备的计量、验证活动;
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;
2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 01-Feb-2026

Closing Date 30-May-2026

Location

苏州
江苏
China
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Attributes

Job type Full time
Contract type Permanent
Salary type Monthly
Occupation Specialist i&ii, manufacturing support
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AstraZeneca
AstraZeneca
297 active jobs
Registered 2024-03-02
China

AstraZeneca is a global, innovation-driven, integrated biopharmaceutical company. Our mission is to make a meaningful difference to patient health through great medicines that bring benefit for patients and add value for our stakeholders and society. We discover, develop, manufacture and market prescription medicines primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. We also work with others to combine complementary skills and strengthen the platform for success in meeting a common goal: improved healthcare. We are active in over 100 countries with a growing presence in emerging markets including China, Brazil, Mexico and Russia. We employ over 50,000 people (13% in the UK, 31% in continental Europe, 29% in the Americas and 27% in Asia, Africa and Australasia). For more information, visit www.astrazeneca.com. Specialties Pharmaceutical, Biopharmaceutical, Innovation, Research and development, Global business
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