验证工程师
宜昌人福药业有限责任公司
- 公司规模:500-1000人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2017-07-18
- 工作地点:宜昌
- 招聘人数:3人
- 学历要求:本科
- 职位月薪:4.5-6千/月
- 职位类别:生物工程/生物制药
职位描述
职位描述:
Job Title: Validation Engineer
Department: QA Dept.
Job Summary:
Lead validation program in conjunction with the Validation Supervisor, manage program for compliance, current strategic alignment and train others. Compile and analyze validation data, prepare protocols, reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files. .
Responsibilities:
Responsible for validation and revalidation of systems, equipment and processes in support of the facility and products in compliance with cGMP requirements.
Responsible for provide assurance that all procedures, operations and systems shall be validated where required. Assure that adequate programs exist in order to support the execution of validation.
Responsible for monitoring the daily operation and maintenance of facility and utility (e.g. HVAC, PW, EMS, CA).
Responsible for monitoring and managing the execution of calibration and preventative maintenance.
Requirements:
Bachelor’s degree in science or other technical field.
2 years of experience in Pharmaceutical Validation activities.
Audit experience is a plus
Fluent in English spoken and written.
Desire /ability to work in an international team.
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Job Title: Validation Engineer
Department: QA Dept.
Job Summary:
Lead validation program in conjunction with the Validation Supervisor, manage program for compliance, current strategic alignment and train others. Compile and analyze validation data, prepare protocols, reports and make recommendations for changes and/or improvements and maintains appropriate validation documentation and files. .
Responsibilities:
Responsible for validation and revalidation of systems, equipment and processes in support of the facility and products in compliance with cGMP requirements.
Responsible for provide assurance that all procedures, operations and systems shall be validated where required. Assure that adequate programs exist in order to support the execution of validation.
Responsible for monitoring the daily operation and maintenance of facility and utility (e.g. HVAC, PW, EMS, CA).
Responsible for monitoring and managing the execution of calibration and preventative maintenance.
Requirements:
Bachelor’s degree in science or other technical field.
2 years of experience in Pharmaceutical Validation activities.
Audit experience is a plus
Fluent in English spoken and written.
Desire /ability to work in an international team.
职能类别: 生物工程/生物制药
关键字: QA主管 质量保证 quality assurance IPQA 现场QA QA 专员 文件管理 QMS
公司介绍
宜昌人福药业有限责任公司是一家具有悠久历史的大型综合性制药企业,公司现拥有总资产29.22亿元,注册资本2.9亿元,员工4300余人,上市公司人福医药集团股份公司和国药集团药业股份公司为公司***、二大股东。宜昌人福药业不仅是人福医药集团旗下规模***、实力最强的子公司,也是我国***的麻醉药品定点研发生产企业。
宜昌人福出口药品生产基地是宜昌人福为实践“国际化战略”斥资6亿人民币打造的集研发生产和销售于一体的高端仿制药制剂公司,自2013年项目成立以来,已有多个自主研发的产品通过FDA官方认证,并有多个OTC产品实现了在欧美等地的销售。
宜昌人福出口药品生产基地是宜昌人福为实践“国际化战略”斥资6亿人民币打造的集研发生产和销售于一体的高端仿制药制剂公司,自2013年项目成立以来,已有多个自主研发的产品通过FDA官方认证,并有多个OTC产品实现了在欧美等地的销售。
联系方式
- 公司地址:地址:span宜昌市东临路519号
- 电话:18271886870