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Technical/ Critical Review QA Director
May 18, 2021
Technical/ Critical Review QA Director
工作职责Job Responsibility
  • 协助计算机化系统文件的建立,确保计算机化系统在上线前按照风险评估的结果进行了合适的验证、在上线后始终保持持续验证状态;Assist in establishment CS document, to ensure that the computerized systems of the business departments served are properly verified according to the results of risk assessment before going online and maintain a continuous verification status after going online;
  • 参加生产设备的概念设计,详细设计,风险评估,URS,设计审核,供应商审计,设计确认,FAT和SAT的执行Participate in the equipment conceptual design, detail design, risk assessment, URS, design review, vendor audit, FAT and SAT execution.
  • 参与生产设备、厂房&公用系统、分析仪器、软件和系统项目的确认/验证工作,即相关文件审核。Participate in equipment, facility and utility system and analysis instrument qualification/validation execution. Review the relevant documents.
  • 负责审核、批准验证文件并参与验证过程中问题的调查分析及变更的评估,确保系统,软件,设备在上线前满足质量和合规要求。Review and approval validation document and take part process problem investigation analysis and change evaluate, Ensure that systems, software and equipment meet quality and compliance requirements prior to launch。
  • 负责审核工艺验证、清洁验证文件,确保满足质量和合规要求。Responsible for review process validation, cleaning validation, to ensure that meet quality and compliance requirements.
  • 参与并审核设备、计算机系统、工艺、清洁相关偏差,变更,CAPA,风险评估过程,确保流程满足GMP要求。Participate in and review the deviation, change control, CAPA, risk assessment, related with equipment, computer system, process, cleaning , and confirm that all process meet the GMP requirement.
  • 负责审核、批准公司设备年度预防性维护计划和年度检验计划,组织其他部门持续提高设备管理流程。Be responsible for company’s equipment pre-maintenance plan and calibration master plan, organize and together other department to continuous improvement the equipment management procedure.
  • 完成上级交代的其它工作任务。Complete other tasks assigned by superior leaders.
基本任职要求Basic Requirement
  • 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.