杭州招聘

Job specification,

1. 为客户提供满足FDA\EMEA\WHO\CFDA的GMP要求的验证咨询服务；
2. 负责医药工程项目的相关验证工作：工艺系统、工艺设备、洁净室、净化空调系统、冷库系统、恒温室的设计;
3. 在制药工程详细设计阶段进行设计确认，对工艺、暖通空调等关键专业进行风险评估；
4. 对已有图纸的设计审核，为客户制定验证总计划（VMP）；
5. 负责对供应商进行审计，编制评估报告；
6. 参与项目施工过程质量、进度控制，参与竣工验收，组织系统调试和测试；审批验证方案和报告，对洁净室性能进行评估；保证竣工的工程产品满足各个国家和地区GMP认证的要求；
7. 负责医药工程项目竣工阶段的FAT\SAT\IQ\OQ\PQ的实施和报告的审核批准

Key qualification,

1. 生物工程、制药工程类相关专业，统招大学本科及以上学历；

2. 有GMP药厂质量管理QAQC工作经验者优先，5年或以上药厂的验证工程经验；

3. 具有良好的英文水平，能够编写英文相关文件，和外籍工程师进行英文沟通；

4. 具备本专业的基本理论知识了解相关专业知识；

5.  细心严谨，能吃苦耐劳，具有团队精神及沟通协调能力，能够适应短期国内外出差

 

Century 3 (Shanghai) Inc. is a leading technology, engineering and project management company in China. With headquarters in Shanghai, we have been operating since 2004. We are granted with Chinese government issued licenses to provide services as: Engineering (Class A Chemical and Building, Class B Petrochemical and Pharmaceutical), Construction (Class I Construction, Class II ME Installation and Interior Decoration), Jianli (Class A Construction Supervision, Class B Municipal Utilities Supervision and Chemical Petroleum Engineering Supervision), and Trading.
We take pride in successfully delivering the best possible value to our clients in automotive, chemical, commercial, food & beverage, general buildings, high-technology, new energy, pharmaceutical and theme park markets with our state-of-the-art technologies including home-developed safety management app, quality management system, facial recognition system and multi-screen BIM work station.
In addition to our China operations, access to internal and external resources based in North America, Europe and South East Asia gives us a pool of experience capable of responding to any client need. Using the passion for professionalism that drives its core guidepost to consistently deliver high quality services, Century 3 is firmly established as an international benchmark for excellence in consulting, engineering, procurement, project management, construction, and maintenance services.