工作职责:
主要参与审计前的准备，审计中的协调，以及审计后的回复和CAPA跟进。
Mainly involved in preparation, coordination, and response to regulatory inspection, client audit and internal audit, as well as CAPAs follow up.
参与定期质量回顾报告的起草，及质量回顾的会议。
Participate in driving regular Quality Review report and quality reviewing meetings.
参与并完成GMP问卷调查。
Participate in driving GMP questionnaires.
协助法规事务。
Support regulation affairs.
完成上级主管安排的其他工作和任务。
Any jobs and responsibilities assigned by the supervisor.
任职资格:
本科及以上
Bachelor degree or above
化学、药学、制药学，或相关化学专业
Chemistry, pharmaceutical, or equivalent experience
良好的普通话/英语的书写/口语交流能力
Good writing/communication skill in Mandarin/English
熟悉MSOffice等办公软件，会使用趋势分析相关工具
Familiar with MSOffice and other office software, and tools for trend analysis
需具有至少3年以上，制药行业GMP质量保证相关工作经验
Should have more than 3 years of working experience on GMP quality assurance in pharmaceutical industry
具有中国药监局，FDA，欧盟GMP法规知识和经验
Experience on NMPA, FDA, EMEA GMP regulation.
具备识别风险/不合规的能力，预防风险的管理和沟通能力
Skills for risk/non-compliance identification and proactive risk management and communication.
能够与来自多元化文化氛围的其他人员合作，积极主动和高效的工作，比如，与跨部门的合作
Proven ability to motivate and work efficiently, with persons from other cultures, as in cross-functional
能够在一定的压力下工作，在规定的时间交付工作
Be able to work under pressure and deliver work timely.