岗位职责：

Responsibilities

1. 负责制定并实施本企业质量策略及方针、全面负责企业质量管理工作；批准与质量相关的SOP，并推行其在公司内部实施；

fine QA strategy of company. Design, implement and improve company’s quality standards; Train, motivate, coach and correct employees to ensure that standards are met.

2. 与企业内外相关部门协调沟通，应对客户及药监部门的审计工作；

ordinate with other departments; Deal with the customer audits and other regulatory inspections.

3. 负责批准原辅料、包装材料、中间体、和成品符合质量标准；

Approve the specifications of raw materials, intermediates, products and packaging materials；

4. 负责批准所有与质量有关的变更、偏差、OOS和验证方案及报告；

Approve all the changes, deviations, oos investigation reports, validation protocols and reports；

5. 批准物料供应商，组织对供应商的审计和评价；

Work with purchasing staffs to establish quality requirements for external suppliers；

6. 组织实施公司质量内审工作；

Organize QA annual self-inspection.

7. 负责组织处理与质量相关的客户抱怨；

Handle of quality related customer complaints

8. 负责指导质量部门的日常工作，并对下属进行培训和考核；

Supervise QA and QC staffs and monitor their performance

任职要求：

Skills and Qualifications

1. 具有药学、化学或相关专业硕士及以上学历，具有至少五年从事大中型知名制药企业的质量管理工作经验；

Master’s degree in pharmacy, chemistry. Five plus years relevant experience of QA management in pharmaceutical industry；

2. 具备出色的质量管理能力，较强的统筹、协调、分析和判断能力，良好的沟通协作能力，优秀的组织和创新能力；

Solid decision making skills. Detail oriented person. Good ability to lead and motivate a team；

3. 熟悉GMP要求下原料药、生产环节的质量控制，善于发现和解决问题；熟悉GMP认证资料准备，有实际的中国、欧盟、FDA的GMP认证经验更佳；

Familiar with the GMP requirements in the process of development and production of APIs. Having experience of dealing with inspections of regulatory organizations is preferred.

4. 良好的英语口语及邮件交流能力，可以顺畅地用英语与国外客户进行交流。

Excellent English communication skills.