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职位信息

职位信息
Technical/ Critical Review QA Director
Apr 16, 2021
Technical/ Critical Review QA Director
中国
Hangzhou
工作职责:
  • 本科及以上学历,生物学、药学等相关专业。至少10年以上生物制药相关工作经验/Bachelor degree or above, major in biology or pharmacy. At least 10 years of working experience in biological pharmaceutical company validation and be familiar with the qualification of facility, equipment /instrument and utilities.
  • 熟悉系统、设备、仪器的确认/验证,熟悉计算机系统验证、软件质量管理相关工作//Be familiar with the qualification or validation of IT system, Equipment and instrument; be familiar with Computerized System Validation, software quality management; be familiar with process validation is a plus
  • 熟悉生物制品工艺流程/Familiar with production process of biological product.
  • 良好的英语听说读写能力,熟练的使用计算机办公软件/Well versed in spoken and written English language, skillful in using computer software.
  • 有较强的分析问题能力及良好的沟通技巧,工作认真、细致,具有良好的团队合作精神/Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.


任职能力:
  • 本科及以上学历,生物学、药学等相关专业。至少10年以上生物制药相关工作经验。Bachelor degree or above, major in biology or pharmacy. At least 10 years of working experience in biological pharmaceutical company validation and be familiar with the qualification of facility, equipment /instrument and utilities.
  • 熟悉系统、设备、仪器的确认/验证,熟悉计算机系统验证、软件质量管理相关工作/Be familiar with the qualification or validation of IT system, Equipment and instrument; be familiar with Computerized System Validation, software quality management; be familiar with process validation is a plus
  • 熟悉生物制品工艺流程/Familiar with production process of biological product.
  • 良好的英语听说读写能力,熟练的使用计算机办公软件/Well versed in spoken and written English language, skillful in using computer software.
  • 有较强的分析问题能力及良好的沟通技巧,工作认真、细致,具有良好的团队合作精神/Excellent communication, problem-solving, and organization skills, attentive, careful and meticulous, with strong team-work ability.
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