质量控制专员
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:2016-11-08
- 工作地点:宜昌
- 招聘人数:1人
- 学历要求:本科
- 职位月薪:3000-4499/月
- 职位类别:生物工程/生物制药
职位描述
职位描述:
Job title: QC Specialist
Department: QC Dept.
Job Summary:
This position is responsible for technical support for Quality Control and ensures the lab activities and relative QC activities comply with cGMP legal and regulatory requirements and the Corporate Quality Manual and EHS Policies. Supports QC head and coaches QC technician.
Responsibilities:
Ensure that the testing and releasing activity comply with the requirements of Policies and meet all relevant cGMP regulatory and legislative requirements.
Ensure that relative Quality System and Standard Operating Procedures are in place and that compliance with cGMP is maintained through training and audit.
Ensure that the logistics for lab managed, QC/IPC testing performed as planned and serve production effectively and efficiently. Ensure that QC processes such as sampling, reagent/reference standards handling, testing and recording, OOE/OOS investigation, testing monograph implementation, training, lab equipment qualification and calibration, test method transferring, computerized system validation are managed according to cGMP.
Train junior staff and provide problem solving/ technical guide on test relative activities.
Responsible for correct data in electronic systems in the QC laboratories.
Responsible for timely implementation of safety, security, industrial hygiene and ecology regulations in Quality Control labs and IPC labs.
Be a valuable team member of Quality organization and develop self and others through close teamwork and cross functional activities such as communication with production & engineering team.
Team member for launch and technical projects.
Requirements:
Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences.
over three years of experience in production.
Excellent English in reading and writing.
Responsible, excellent communication and coordination skills, strong learning ability.
Familiar with cGMP and FDA regulation preferred
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Job title: QC Specialist
Department: QC Dept.
Job Summary:
This position is responsible for technical support for Quality Control and ensures the lab activities and relative QC activities comply with cGMP legal and regulatory requirements and the Corporate Quality Manual and EHS Policies. Supports QC head and coaches QC technician.
Responsibilities:
Ensure that the testing and releasing activity comply with the requirements of Policies and meet all relevant cGMP regulatory and legislative requirements.
Ensure that relative Quality System and Standard Operating Procedures are in place and that compliance with cGMP is maintained through training and audit.
Ensure that the logistics for lab managed, QC/IPC testing performed as planned and serve production effectively and efficiently. Ensure that QC processes such as sampling, reagent/reference standards handling, testing and recording, OOE/OOS investigation, testing monograph implementation, training, lab equipment qualification and calibration, test method transferring, computerized system validation are managed according to cGMP.
Train junior staff and provide problem solving/ technical guide on test relative activities.
Responsible for correct data in electronic systems in the QC laboratories.
Responsible for timely implementation of safety, security, industrial hygiene and ecology regulations in Quality Control labs and IPC labs.
Be a valuable team member of Quality organization and develop self and others through close teamwork and cross functional activities such as communication with production & engineering team.
Team member for launch and technical projects.
Requirements:
Bachelor degree or above, majored in pharmaceuticals, chemistry or related sciences.
over three years of experience in production.
Excellent English in reading and writing.
Responsible, excellent communication and coordination skills, strong learning ability.
Familiar with cGMP and FDA regulation preferred
职能类别: 生物工程/生物制药
关键字: QC专员 检测员 HPLC QC主管 质量控制 质量管理
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