审计QA

工作职责Job Responsibility：

1. 遵守公司的规章制度，遵守保密制度，坚持保密原则 Obey the regulations of company, obey the confidential regulation and insist the confidential principle.

2. 在确保合规的基础上，协助部门优化流程，预防或降低问题的发生；

Assist the department in optimizing processes based on compliance to prevent or reduce the occurrence of issues

3. 审计管理 Audit management

a. 参与内审计划的制定和开展 Responsible for generating the internal audit plan and implementation of the internal audit.

b. 负责客户审计和官方检查的计划、准备和接待 Responsible for scheduling, preparation and reception of the client audits and regulatory agency inspections.

c. 负责内审、客户审计和官方检查的回复和纠正预防措施的跟踪，确保按计划时间完成 Responsible for the tracking the observation response and CAPA implementation of the internal audit, client audit and regulatory inspection, ensuring the completion as per defined schedule.

d. 负责相关 SOP 的维护和解答 Responsible for maintenance and explanation of related SOPs.

e. 负责审计相关记录的管理和定期归档 Responsible for maintenance of audit related documents and archiving periodically.

f. 负责审计团队的日常管理工作

4. 领导安排的其他工作 Other jobs assigned by the supervisor.

任职要求Requirement：

1. 具备医药或相关专业本科以上教育背景；

With the education background of medicine or relevant major of bachelor or above.

2. 具有3年或以上的制药行业工作经验 Over 3 years of experience in pharmaceutical.

3. 生物制药和无菌生产等相关 GMP 知识；熟悉 GMP 法规知识 GMP knowledge related to Biopharmaceutical and Aseptic production; Familiar with GMP Regulations.

4. 熟悉办公软件及统计软件的使用 Familiar with the operation of statistical software and office software

5. 认真细致，较强的团队合作能力和沟通协调能力 Careful and meticulous, with strong ability on team-work, communication and coordination

6. 良好的英语口语和书面英语 Good oral and written English

7.具有团队管理经验为加分项