Validation Manager

Validation

Your new company

Your new role
1. 新建符合FDA 标准要求的无菌制剂生产厂房的验证体系,并确保有效运行。 2. 起草、审核通过FDA 认证所需的验证相关文件 3. 组织公司各部门有序开展验证工作,包括设备验证、清洁验证和工艺验证,并在验证过程中做好各部门的沟通和协调。 4. 完成上级领导安排的其他工作 5. 培训团队其他成员。

What you'll need to succeed
1. 本科及以上学历,制药工程或药学相关专业, 2.5 年以上制药行业验证管理经验,至少具备2 年非最终灭菌产品生产或验证经验; 3. 熟悉国内外GMP 法规要求,熟悉无菌制剂生产要求、设备验证要求、无菌保障要求。 4. 能够独立起草验证主计划;具备审核公司各类验证的能力。 4.1 具备起草和组织执行无菌制剂工艺验证和清洁验证的能力; 4.2 具备起草和组织执行无菌制剂设备验证(URS FAT SAT DQ 、IQ 、OQ 、PQ )的能力 。 5. 熟悉验证管理体系,偏差管理体系,变更管理体系,CAPA 等; 6. 具有较强的解决问题和沟通能力,积极主动, 良好的团队合作意识。

What you'll get in return

What you need to do now
If you're interested in this role, click 'apply now' to forward an up-to-date copy of your CV, or call us now.
If this job isn't quite right for you but you are looking for a new position, please contact us for a confidential discussion on your career. #1220575

Summary

Job Type
Permanent
Industry
Pharmaceuticals
Location
Shanghai
Specialism
Life Sciences
Ref:
1220575
Closing date
31 Jan 2023

Talk to a consultant

Talk to Lennie Wang, the specialist consultant managing this position, located in Shanghai
Unit 1205-1212, HKRI Centre One, HKRI Taikoo Hui, 288 Shimen Road (No.1)

Telephone: +8602123229709

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