1. 质量保证专员职责描述（全职）
Quality Assurance Specialist Job Description (full time)
关键技能Key Skills
• 英语说写流利
English language fluency, both oral and written
• 成熟专业的态度
mature and professional deportment
• 至少2年的行业内质量保证工作经验
minimum of 2 years experience working in industrial Quality Assurance
• 在制药或生物制药业有至少2年工作经历
minimum of 2 years experience working in pharmaceutical or biotechnology industry
• 对国际国内的cGMP要求有一定的理解
understand international and domestic cGMP requirements
• 会编写SOP
can write SOPs
• 根据需要在客户现场提供支持
provide support at client site as required
• 监控CFDA政策的行动和变更，准备中英文总结报告
monitor activities and changes to CFDA policies and prepare summary reports in Chinese and English
典型工作项目举例
Examples of Typical Work Projects
• 文件准备和审核
document preparation and review
o 为客户准备中文或双英文的文件
prepare documents in Chinese or bilingual for client
o 代表客户QA部门审核QA和验证文件
review QA and validation documents on behalf of client QA department
• 供应商检查inspection of supplier
o 审计供应商材料，确定其cGMP 的符合性，评估客户使用该供应商相关的风险
audit supplier of materials to determine extent of compliance with cGMP and to evaluate risk associated with use of supplier by client
• 项目管理
project management
o 代表远方客户提供当地服务
represent distant client with local provider of service
o 准备定期报告，更新客户
prepare regular reports to update client
o 和供应商一起解决客户关注点
work with vendor to resolve client concerns
o 跟踪计划表和问题，确保及时完成供应商行动
track schedule and issues to ensure timely completion of vendor activities
• 差距分析
gap analysis
o 审核客户现有QA系统，确定客户系统与完全符合cGMP要求之间的偏差（差距）
review current QA systems at client and determine deficiencies (gap) between where client system is and where it should be for full cGMP compliance
Complya Asia provides consulting services to pharmaceutical and other healthcare related clients. Our focus is assisting companies to meet international standards for quality assurance. Our clients include a wide variety of domestic Chinese and international corporations. We provide the best service in our field and work diligently to maintain our reputation for high quality and professional performance. We are affiliated with the Complya Consulting Group in Boston (www.complya.com). Position reports to Scott M Wheelwright PhD.
苏州智真为制药和其他医疗保健相关的客户提供咨询服务。我们致力于协助客户达到质量保证的国际标准。我们的客户包括广泛的各类国内外企业。我们在领域内提供最优的服务，致力于保持我们高质量、专业服务的口碑。我们公司隶属于位于波士顿的Complya Consulting Group (www.complya.com)公司。该职位向Scott M Wheelwright博士汇报。
