Job Purpose:

依据公司和部门质量目标，协助质量管理部经理做好质量管理工作；参与公司质量保证体系改进工作和健全药品质量保证体系；协助监督指导药品购进、验收、养护、储存、配送、运输、销售等环节的药品质量管理工作和药品第三方物流的质量监督工作。
According to the company and department quality objectives, assist the QA manager’ work for quality management; participate in the work for quality management system improve; assist in the quality management work of supervising and guiding drug purchase, acceptance, maintenance, storage, distribution, transportation and sales; also the quality supervision for third-party logistics.

Responsibilities:

1 根据GSP法规收集和维护供应商，客户，产品首营资料，并在计算机系统中建立/维护质量基础数据，建立质量档案，并进行动态管理；

Collect and maintain the documents for supplier, customer, product according to the GSP regulations, and establish/maintain quality master data in the computer system; establish quality archives and manage them dynamically; 2 负责GSP质量管理体系文件和记录的管理工作；根据GSP和CSL总部要求编写SOP和文件；

Responsible for quality management work for SOP and record, draft SOPs and records according to local regulation and CSL global policy

3 负责质量信息收集和质量查询工作；

Responsible for quality information collection and quality inquiry；

4 负责药品经营数据上传到药监局数据库；

Responsible for uploading drug operation data to the database of the Drug Administration;

5 协助完成质量内审和药监部门检查工作；

Assist for quality internal audit work and health authority inspection;

6 协助质量培训工作；

Assist for quality training work;

7 跟进质量事故、质量投诉和药品不良反应处理等相关工作；

Follow up the work of quality accidents, quality complaints and adverse drug reactions;

8 参与药品经营的质量风险管理

Participate in quality risk management for drug distribution operations;

9 退货、不合格品的跟踪处理；

Follow up the handling of returns and rejected products;

10 领导交代的其它工作。

Other work that the leadership explained.

Requirements:

• 具有药学、或者医学、生物、化学等相关专业的本科以上学历，有执业药师证优先

Bachelor degree or above with pharmacy, or medical, biological, or chemical related majors, with licensed pharmacist certificate preferred

• 从事药品经营管理工作2年以上的优先或具有同等资历/工作经验

Priority in the pharmaceutical companies for more than 2 years or equivalent qualifications/work experience

• 熟悉国家和广东省药品经营管理的法律法规和药品第三方物流管理的法律法规；

Familiar with laws and regulations of drug administration and 3PL management in the State and Guangdong Province; · 能熟练操作电脑和使用Microsoft office工具，包括但不限于：word, excel, powerpoint和Visio Proficiency in computer operation and use of Microsoft office tools including but not limited to: word, excel, powerpoint and Visio

• 能用英语起草SOP和书写邮件

Ability to write SOPs and Email in English

• 工作认真细心、诚实，具备良好的学习能力、沟通能力和团队协作精神，责任心强，能积极主动和快速响应。

Work carefully, honestly, with good learning, communication and teamwork spirit, strong sense of responsibility, proactive and responsive

上班地址：广州市天河路230号万菱国际中心40楼05-06单元