工作职责:
主要职责
Responsibilities
1. 负责协调国内/国际药监机构及客户核查、GMP检查的准备工作。支持海外注册质量相关事务。
Responsible for coordinating the readiness of Audits, GMP inspections conducted by regulatory agencies from both local and abroad, as well as by clients. Support oversees registration on Quality.
2. 负责支持药监部门的各项常规检查及监督抽查（检），并在规定工作日内，督促有关部门将回复上报药监部门；与药监机构沟通许可相关的事宜。
Responsible for supporting the kinds of inspections conducted by HA, urge relevant departments to submit responses regarding to HA within specified days; communicate with HA regarding licensure related affairs.
3. 支持质量管理体系的建立和完善。
Supporting the establishment and improvement of quality management systems.
4. 负责药品年度报告的维护和更新。
Responsible for the maintenance and update of the Annual Report of Drug Product.
5. 参与质量管理活动和质量系统的管理审评，维护质量体系运营相关KPI的管理。
Participate in the quality management activities and the management review of the quality system, and maintain the management of KPI's related to quality system operations.
6. 确保有及时有效的沟通机制和逐级汇报程序，将质量问题提交到适当的管理层。
Ensure effective and timely communications of quality issues, with escalation process to appropriate management level.
7. 参与部门及团队管理，激励、培训并指导小组成员的工作和绩效。
Participate in management of department and team, motivate, training and guide the work and performance achievement of team member.
8. 支持国际化合作项目，包括但不限于提供各类与质量相关的注册/申报文件、质量相关文件，和（或）质量相关业务办理等。
Support to international projects, including but not limited to providing registration/application documents in quality scope, quality-related documents, and/or quality-related business processing etc..
9. 完成上级交办的其它事务。
Other tasks assigned by line manager.
任职资格:
任职要求
Requirement
1. 药学、生物学或相关专业，本科或以上学历。
Bachelor's degree or above, and experience in pharmacy, biology or related majors.
2. 具有制药企业至少8年以上的质量体系或合规工作经验，熟悉药品GMP审计/检查工作。具有跨国制药公司工作经验者尤佳。
At least 8 years quality system or compliance working experience in pharmaceutical company and be familiar with GMP inspection/audit. Experience in global pharmaceutical company is highly preferred.
3. 熟悉国内外药品GxP相关法规/规范的要求。
Familiar with the requirements of local and foreign drug products GxP related laws/regulations.
4. 具有良好的协调能力和沟通能力，具有独立思考和分析能力。
Good coordination and communication skills and independent thinking and analytical skills.
5. 掌握常用的办公软件，及良好的英语读写能力。
Good command of office software and good English reading and writing skills.
6. 具备团队协作精神及工作责任感。
Teamwork spirit and sense of responsibility.