YOUR TASKS AND RESPONSIBILITIES

• Organize and coordinate the execution of CMS documentation from headquarter. Search and review the most updated official drug regulation, coordinating management of new regulation, including analysis, implementation and actions follow-up.
• 组织并协调总部质量体系文件的执行。搜寻并审阅最新的本地药品法律法规，组织对新增法律法规的风险分析，执行和行动跟进。
• Create Annual GMP training plan for Guangzhou Site and organize special GMP training (such as auditor training).
• 制定广州工厂年度GMP培训计划，组织GMP专项培训（例如审核员培训）。
• Organize and implement the self-inspection of Guangzhou Site, follow up the implementation of CPAPs.
• 组织和实施广州工厂的内部审核，跟进纠正和预防措施的执行情况。
• To assist supervisor in completing drug supervision matters, such as information preparation, filling, submission, etc.
• 协助主管完成药监事务：例如资料准备、申报、各种报告的递交等。
• Involve in risk analysis of equipment, process and regulation as Quality function, follow up the CAPAs and manage the documentation of risk analysis reports.
• 作为质量部参与广州工厂的设备，过程的风险分析，跟踪CAPA 和风险分析报告的文件管理。
• Cooperate Guangzhou site's qualification and validation activities, involves in activities of qualification and validation as Q function.
• 负责协调工厂的确认和验证工作，作为质量部参与确认和验证活动，保证确认验证活动符合GMP要求。
• Performs the other works assigned by the supervisor in a positive manner in order to ensure smooth and efficient operation
• 用积极的态度及时执行上级安排的其它工作以保证流程的正确有效运作

 WHO YOU ARE

• Education 学历：
  • University graduate or above in pharmacy or related major
  • 药业或相关专业本科以上学历
• Experience 经验：
  • Atleast 2 years relative work experience in GMP auditing.
  • GMP审核方面2年以上工作经验
• Knowledge & Skills知识和技能:
  • Knowledge of GMP regulations and guidelines GMP法律法规 Spoken and written
  • English reach CET-4 英语口语和书写达到CET-4 Good at computer operation 良好的计算机操
  • Good organization and communication skill with others
  • 良好的组织和沟通能力
  • Patience and careful 耐心细致