Senior GMP Specialist
嘉科工程（上海）有限公司
- 公司规模：10000人以上
- 公司性质：外资(欧美)
- 公司行业：石油/化工/矿产/地质 建筑/建材/工程
职位信息
- 发布日期：2017-03-09
- 工作地点：上海
- 招聘人数：1人
- 工作经验：10年以上经验
- 学历要求：本科
- 语言要求：英语 熟练
- 职位月薪：2.5-3万/月
- 职位类别：其他
职位描述
职位描述：
Major Responsibilities:
The Senior GMP Specialist takes the leading role of GMP activities in engineering projects and lead cGMP consulting for clients. Responsibilities include planning, coordinating, and leading the GMP activities in engineering projects; developing quality management system to ensure continuous production in compliance with GMP regulations; and leading process/clean/computer validation practices.
Capability and Competence:
? B.S,or above in pharmaceutical sciences, chemistry, chemical engineering, or a related discipline
? 10+ years experience in pharmaceutical manufacturing quality management functions
? Intimate familiarity with the CFDA GMP, U.S. FDA cGMP and EU GMP standards.
? Lead GMP activities during engineering projects, including preparing VMP, GMP brief, leading risk assessment etc.
? Lead the design, creation, training and implementation of Quality Management System.
? Experience in pharmaceutical manufacturing including sterile, solid production etc.
? Intimate knowledge of critical equipment, process, and utilities design, installation, commissioning, qualification, validation, and maintenance
? Excellent English communication and writing skills.
? Ability to travel for extended periods of time, possibly up to 2-3 months at a time.
? Vendor audit experience
Evaluation / Performance Indicators:
? Quality assurance experience
? Pharmaceutical process knowledge including key unit operations, equipment and critical utilities
? cGMP know-how
? Pharmaceutical production experience
? English capability
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Major Responsibilities:
The Senior GMP Specialist takes the leading role of GMP activities in engineering projects and lead cGMP consulting for clients. Responsibilities include planning, coordinating, and leading the GMP activities in engineering projects; developing quality management system to ensure continuous production in compliance with GMP regulations; and leading process/clean/computer validation practices.
Capability and Competence:
? B.S,or above in pharmaceutical sciences, chemistry, chemical engineering, or a related discipline
? 10+ years experience in pharmaceutical manufacturing quality management functions
? Intimate familiarity with the CFDA GMP, U.S. FDA cGMP and EU GMP standards.
? Lead GMP activities during engineering projects, including preparing VMP, GMP brief, leading risk assessment etc.
? Lead the design, creation, training and implementation of Quality Management System.
? Experience in pharmaceutical manufacturing including sterile, solid production etc.
? Intimate knowledge of critical equipment, process, and utilities design, installation, commissioning, qualification, validation, and maintenance
? Excellent English communication and writing skills.
? Ability to travel for extended periods of time, possibly up to 2-3 months at a time.
? Vendor audit experience
Evaluation / Performance Indicators:
? Quality assurance experience
? Pharmaceutical process knowledge including key unit operations, equipment and critical utilities
? cGMP know-how
? Pharmaceutical production experience
? English capability
职能类别： 其他
公司介绍
Jacobs Engineering Group Inc.是全球最大的工程公司之一，总部位于美国加利佛尼亚州的帕萨迪纳。公司集团成员分布在全球30多个国家和地区，公司拥有超过200个公司集团成员，全球拥有65,000名员工。公司向全球范围内的客户提供多元化的技术、专业和工程建设服务，在2012年度获得了超过100亿美元的收入。
Jacobs Projects(Shanghai) Co. Ltd. 嘉科中国简介：
A world-class contractor serving international companies
服务于国际公司的世界级承包商，在中国涉及的行业有
Architectural 建筑
Pharmaceutical 制药
Chemical / Petrochemical 化工 / 石化
Permanent Shanghai,Zhuhai, Chengdu, Xian, Taiyuan offices
在上海、珠海、成都、西安、太原拥有办公室
300 projects executed in China since 1978
自1978年始在中国执行的项目超过300个
600 bilingual professional employees
中国地区拥有600位员工
Proven project execution capabilities
拥有强大的项目执行力
Close cooperation with Chinese design institutes, Chinese construction companies and local authorities
与中国的设计院、施工单位及地方政府之间密切合作
Jacobs Projects(Shanghai) Co. Ltd. 嘉科中国简介：
A world-class contractor serving international companies
服务于国际公司的世界级承包商，在中国涉及的行业有
Architectural 建筑
Pharmaceutical 制药
Chemical / Petrochemical 化工 / 石化
Permanent Shanghai,Zhuhai, Chengdu, Xian, Taiyuan offices
在上海、珠海、成都、西安、太原拥有办公室
300 projects executed in China since 1978
自1978年始在中国执行的项目超过300个
600 bilingual professional employees
中国地区拥有600位员工
Proven project execution capabilities
拥有强大的项目执行力
Close cooperation with Chinese design institutes, Chinese construction companies and local authorities
与中国的设计院、施工单位及地方政府之间密切合作
联系方式
- Email：hr.china@jacobs.com
- 公司地址：上班地址：浦东新区世纪大道1701号中国钻石交易中心南塔B区6层