1、教育背景：化学、应用化学、药学或其他相关专业本科及以上学历。
Education Background: Chemistry, Applied Chemistry, Pharmacy or other relevant education background, bachelor degree and above.
2、经验：具有至少五年从事药品生产和质量管理的实践经验，其中至少两年的药品质量管理经验，接受过与所生产产品相关的专业知识培训（或中级专业技术职称或执业药师资格）。
Experience: At least 5 years’ practical experience in the field of quality management and manufacture in pharmaceutical industry or drug research & development area, at least 2 years’ experience in quality management, have received professional knowledge training related to the products (or intermediate professional technical title or licensed pharmacist qualification).
3、技能技巧：具有一定的英语能力，应能与国外客户进行有效的沟通。
Skills: English proficiency is required to communicate with foreign clients effectively.

1、在QA执行总监领导下执行北京园区CMC 部门GMP的质量保证工作。
Responsible for the quality assurance work in CMC division of Pharmaron Beijing site, under the leadership of QA Executive Director.
2、学习国内外药品法律、法规，确保质量保证工作的合规性。
Learn the national and international pharmaceutical laws and regulations, ensure the compliance of quality assurance work.
3、依据《药品生产质量管理规范》、ICH、EU GMP、FDA GMP 等国内外相关法律，完善质量保证体系，指导整个质量体系中的相关活动。
According to the regulations of China GMP, ICH, EU GMP, FDA GMP, improve quality assurance management system and guide the quality activities in entire quality system.
4、负责外部审计的接待及后续CAPA 行动的协调及追踪，以持续改进质量管理体系，并满足客户的要求。
Receive the external audit, and coordinate and track the implementation of the corresponding CAPA, to continuously improve the quality management system and satisfy the requirement of client.
5、审核GMP质量体系相关SOP及OG，并负责文件体系管理，确保文件体系按法规及公司相关规程执行
Review SOP and OG of GMP quality system, and responsible for the document system management, to ensure the document system runs following the regulations and the procedures of company.
6、负责培训体系管理及人员考核。
Responsible for the training management and personnel examination.
7、协调并参与公司内部质量审计及后续CAPA行动的协调及追踪。
Coordinate and participate in the internal audit, and coordinate and track the implementation of the corresponding CAPA .
8、负责维护和管理客户相关的质量协议，确保项目按质量协议执行并满足客户要求。
Maintain and manage the quality agreement associated with client, to ensure the production project runs following the quality agreement and satisfy the requirement of client.
9、填写并管理外部客户提交的调查问卷。
Fill in and manage the questionnaire from client.

上班地址：泰河路6号