QA supervisor/manager
上海人才有限公司
- 公司性质：外资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2013-01-15
- 工作地点：上海
- 招聘人数：1
- 工作经验：五年以上
- 学历要求：本科
- 语言要求：普通话精通
英语良好 - 职位类别：药品生产/质量管理 生物工程/生物制药
职位描述
Job description:
Our client is one of the world's largest CRO company which is focus on comprehensive drug development services. They are now looking for an excellent candidate to join their GLP team and take the responsibility to manage and implement the overall quality program for the lab.
Responsibilities:
- Performing quality oversight on the aspects of pharmaceutical projects
- Ensure qualification and validation activities in Technical compliance with relevant company policy, headquarter guideline and regulatory requirements
- Manage the validation and qualification program for facilities, systems, shippers, and equipment
- Facilitate communication and interact with management and clients to resolve compliance issues
- Prepare, review and/or approve: SOPs, protocols, forms, reports and with coordination from global Quality Team
- Provide training to team members
Requirements:
Education& Experience:
- B.S. with 5-8 years experience or M.S. with 3-5 years experience in pharmaceutical/CRO industry with three years in Quality Assurance
- Understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
- Excellent technical knowledge and strong knowledge in pharmaceutical regulations and guidance for GMP, GLP, GCP
- Be able to provide advises to client in areas such as: facility utilities, qualification, validation, and quality/manufacturing operations
Languages:
-Good communication skills, both written and verbal in English
Computer skills:
- Proficient in Word/Excel/Access/PowerPoint/Microsoft project
Benefits:
- Opportunity of working with multi-cultural professional team
- Competitive salary and good career development opportunity
- Good company culture and multiple training courses
Our client is one of the world's largest CRO company which is focus on comprehensive drug development services. They are now looking for an excellent candidate to join their GLP team and take the responsibility to manage and implement the overall quality program for the lab.
Responsibilities:
- Performing quality oversight on the aspects of pharmaceutical projects
- Ensure qualification and validation activities in Technical compliance with relevant company policy, headquarter guideline and regulatory requirements
- Manage the validation and qualification program for facilities, systems, shippers, and equipment
- Facilitate communication and interact with management and clients to resolve compliance issues
- Prepare, review and/or approve: SOPs, protocols, forms, reports and with coordination from global Quality Team
- Provide training to team members
Requirements:
Education& Experience:
- B.S. with 5-8 years experience or M.S. with 3-5 years experience in pharmaceutical/CRO industry with three years in Quality Assurance
- Understand, analyze and communicate the impact of global regulatory issues affecting the drug development process
- Excellent technical knowledge and strong knowledge in pharmaceutical regulations and guidance for GMP, GLP, GCP
- Be able to provide advises to client in areas such as: facility utilities, qualification, validation, and quality/manufacturing operations
Languages:
-Good communication skills, both written and verbal in English
Computer skills:
- Proficient in Word/Excel/Access/PowerPoint/Microsoft project
Benefits:
- Opportunity of working with multi-cultural professional team
- Competitive salary and good career development opportunity
- Good company culture and multiple training courses
公司介绍
上海人才有限公司诚聘
联系方式
- 公司地址：北京市