Qualifications (minimum requirements) 任职资格

Education Background: 教育背景

• 4-yr (BS) Degree or above in automation, Pharmaceuticals Engineering or related field 自动化、药学, 工程学或其他相关领域学科4 年本科学士学位或以上

• Fluent in written and spoken English

良好的英语书写和沟通能力

Professional Experience专业经验:

• Minimum 5 years of experience in Pharmaceuticals industry，3 years quality assurance, and/or working in a similar position is preferred.
至少5年只要行业工作经验，3年质量保证相关岗位工作经验优先。

• Microbiology test related working experience is preferred
微生物实验相关经验优先

• Previous work experience related to equipment qualification and method validation for Microbiology test is preferred.

最好有微生物实验相关仪器和方法验证工作经验

• Ability to worked effectively in cross- organizational networks 能够高效的跨部门合作

• Ability to motivate and lead process improvements for responsible area. 具备较好的推动和主导所负责区域流程的改进能力

• Good knowledge on regulatory requirements and expectations of cGMP and pharmacopeia from NMPA and EU for Microbiology testing related part.
熟悉国家食品药品监督管理总局和欧盟法规及药典要求,尤其是微生物实验相关的部分。

• Good communication skill and be able to convince internal stakeholders on disagreements.
具备良好的沟通能力，当有不用意见能够说服相关方以达成一致

Job content工作内容描述

Purpose of the Job 职位目标:

The QA engineer is responsible for quality assurance related matters in automation related area for new line introduction and routine operation in NN Site Tianjin, ensuring high compliance with GMP requirements. Assist manager to make right decision from quality point of view.

该质量保证工程师负责诺和诺德天津工厂产线引入和日常运营的自动化相关质量保证事务，以保证所有生产活动和工作流程高度符合GMP的要求。从质量的角度协助经理做出正确的决策。

Main Job Tasks 岗位职责:

• Provide quality and compliance related input and make decisions on quality and compliance related issues.
对质量和合规相关问题给出建议和意见，并决定处理方法。

• Related Validation documents approval
相关验证文件的批准。

• Establish SOPs for quality related processes and procedures where relevant
建立质量相关流程和操作程序的SOP。

• Provide training to employees within and outside of the quality assurance department. 向员工提供质量相关培训。

• Handle and answer internal and external (authority) audits and regulatory affair inquiries. 应对内、外部审计和检查，回答法规事务调查和询问。

• Review and approve operational documents requiring QA approval, including but not limited to:
审核并批准所有需要QA批准的操作性文件，包括但不限于：

o Standard operating procedure (SOP) 标准操作规程

o Change requests 变更(CR)

o IT incident IT事件

o IT Periodical System Evaluation IT 系统阶段性回顾

其他信息
语言要求：英语