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职位信息

职位信息
SEM-高级验证工程师
May. 18, 2021
SEM-高级验证工程师
中国
无锡
工作职责:
  • Ensures that the commissioning and qualification of the commercial manufacturing facility comply with appropriate regulatory requirement and construction code; 
  • Lead the C&Q project implementation;
  • Coordinate all parties in C&Q execution; 
  • Support validation related audit/visit by clients and regulatory authorities; 
任职能力:
  • 教育程度/经验Education background/ Experience 
  • Bachelor degree or Above
  • 特别知识Special knowledge
  • Familiar with regulatory requirements and industry standards, such as 21 CFR Part 210/211/11, Annex 11 of EU GMP, GAMP 5, ICH Q9/Q10; ISPE baseline guides, and PDA TRs in cleaning and process. 
  • 技能Skills 
  • Be experienced in validation and qualification activities and system lifecycle form requirements analysis or product development to commercialization manufacturing, covering various equipment/facilities/utilities/computer systems or cleaning/analytical methods/processes. 
  • 其他要求(比如工作时间等)Other requirements
  • At least 8 years of working experience in validation     

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