1. 教育程度/经验
大学本科及以上学历，药学或相关专业毕业 At least university degree, major in pharmaceutical or related subjects
至少在制 药行业5年以上质量管理相关的工作经历 Above 5 years of working experience in pharmaceutical industry
良好的英语技能 Good command of English
良好的计算机技能 Good Computer skill
良好的个性，工作努力，强的质量意识和服务意 识Good personality, hardworking, strong quality mind, strong service mindset


2.工作职责
1. 负责质量体系团队的日常管理。 Daily management of quality system team.
2. 创建，维护并改进质量管理系统以符合GMP和相关法规的要求。 Create, maintain and improve the quality management system to meet the requirements of GMP and relevant regulations
3. 负责维护GMP文件/记录管理系统/档案管理，确保有效运行。 Responsible for maintaining the GMP document/record management system/archive center to ensure effective operation
4. 负责维护工厂培训系统，组织GMP培训课程 并提高公司员工的GMP知识储备。协调MC和TW系统 Oversee the factory training system, organizing GMP training courses and improving the company's staff's GMP knowledge reserve. Coordinate MC and TW system
5. 维护工厂的变更，CAPA，质量风险等 质量体系，确保有效运行。 Maintain the factory's change, CAPA, quality risk and other quality systems to ensure effective operation.
6. 定期组织质量管理评审，促进质量体系改进。 Regularly organize quality management review to promote quality system improvement
7. 负责客户投诉和产品召回的内容。 Responsible for the client complaint and product return, withdrawal or recall activities, as needed
8.协助审计团队日常客户审计或法规机构审计。对任何发现项提供及时的响应 和跟踪。 Assist audit team in daily client or hosting regulatory inspections. Providing timely response and follow-up to any assigned observations.
9.参与内部审计程序的执行，评估公司的CGMP操作的依从性。 Participate in the execution of the internal auditing program to evaluate the comp


3.其它技能
会使用SAP，Track wise，Master Control等大型GMP电子系统