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QA 主管/经理 QA Manager / Director

 
岗位信息
  • 更新时间:2020-05-07
  • 学历:本科
  • 工作地点:江苏省-南京市
  • 语言要求:英语
  • 工作年限:1年以下
  • 招聘人数:11
  • 月薪:0-0元
  • 性质:私营企业
岗位要求
岗位职责:
QA Manager / Director Duties and Responsibilities1. Assure compliance of APIs manufacturing with cGMP; 2. Manage the validation program for processes, cleaning, equipment, utilities, facilities, and computer systems, as well as stability programs; 3. Responsible for review and approval of laboratory OOSs and manufacturing deviations and investigations; 4. Provide internal and external auditing; 5. CAPA and management reviews; 6. Carry out performance reviews with QA personnel in accordance with the Company performance management system;7. Ensure that all GMP related documentation is regularly reviewed and updated in accordance with Company policy;8. Review and approve product quality review reports;9. Plan and ensure delivery of training and on-going development for QA personnel.

Requirements1. Bachelor’s degree or advanced degree in a science, engineering, or related field;2. Thorough knowledge of cGMP;3. At least five years experience in implementing or maintaining compliant quality systems;4. At least three years experience in a FDA and/or EDQM approved API Facility; 5. Have excellent interpersonal, problem solving, and communication skills;6. Ability to read and speak English.
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