职位信息

• 负责客户审计和官方审计的计划，准备，接待，回复和纠正预防措施的跟踪；Responsible for the planning, preparation, reception, reply and CAPA follow up of customer audit and regulatory audit;
• 负责年度内审的计划，安排和实施；Responsible for the planning, arrangement and implementation of annual internal audit;
• 负责质量管理回顾和风险管理工作；Responsible for quality management review and risk management routine works;
• 完成领导交办的其它工作。Other work assigned by superior leader.

教育程度/经验Education background/ Experience

• 本科及以上学历，生物制药相关专业；Bachelor degree above, biopharmaceutical major;
• 5年以上药品或生物制药QA的工作经验

教育程度/经验Education background/ Experience

• 本科及以上学历，生物制药相关专业；Bachelor degree above, biopharmaceutical major;
• 5年以上药品或生物制药QA的工作经验；At least 5 years of pharmaceutical QA management experience

特别知识Special knowledge

• 熟悉欧盟，中国和美国GMP法规相关要求。Familiar with EU, CFDA, FDA GMP regulations and requirements.

技能Skills

• 较好的英语读写和对话能力；Good English reading and writing skills and good communication ability;
• 有良好的沟通技巧和团队合作精神；Good communication and team work;
• 熟练的使用计算机办公软件。Skilled use of office software.

其他要求（比如工作时间等）Other requirements (e.g.: working time)

• 服从其他工作安排。Obey other work arrangement.