Qualifications (minimum requirements) 任职资格：

Education Background: 教育背景：

4-yr (BS) Degree or above in Pharmaceuticals, microbiology, biology related field.

药学,制药,微生物/生物或其他相关领域学科4 年本科教育学士学位或以上。

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 Pharmaceutical industry including production and/or quality assurance experience. 至少5制药行业经验包括生产或QA相关岗位工作经验。

1~3 years knowledge and experience in aseptic processing or QA assurance related area are preferred.

***有1~3年的质量保证，无菌生产相关领域的知识和经验

Good knowledge on regulatory requirements and expectations from NMPA and EU.

熟悉国家食品药品监督管理总局和欧盟法规要求

Ability to worked effectively in cross- organizational ｎｅｔworks

能够高效的跨部门合作

Ability to influence department/process performance

具备影响负责部门/流程能力

Job content工作内容描述：

Purpose of the Job 职位目标:

The senior QA engineer is responsible for all quality assurance related matters for Environment Monitoring department in NN Site Tianjin, ensuring high compliance with GMP requirements. Assist manager to make right decision from quality point of view. Support other QA colleagues with technical knowledge. Support stakeholders when they consult about compliance questions.

高级质量保证工程师负责诺和诺德天津工厂环境监控部门所有质量保证相关的事务，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。向其他质量保证工作人员提供专业技术知识培训；向其他同事提供合规相关问题的咨询意见。

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。

Perform QA presence for responsible area and handling relevant issues.

在自己负责领域内做QA监察并处理相关问题。

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 affairs inquiries.

应对内、外部审计，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：

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

-Batch production record （BPR) 批记录文件

-Non-conformities 偏差

-Internal complain and customer complain 内部投诉和客户投诉

-Change requests （CR） 变更

-Quality activity plans 质量活动计划（QAP）

-Preventative maintenance plan 预防维修计划

-Calibration specification sheets 校准说明书

-Logbook 日志

-Annual product review (APR) 年度产品回顾

Other individual assignments 其他 :

Incorporate Novo Nordisk Way (NNW) into daily way of working

将诺和诺德之道（NNW）融入到日常工作中

Other work assigned by line manager.

直线经理安排的其他工作。

Keep line manager accurately informed of work status as well as any problems

保证将工作状态和所有问题准确通知到直线经理

Perform role of process responsible in regard to quality and compliance when assigned by line manager.

当直线经理指定时，担任质量和合规的流程负责人。

Keep Ready for travel both domestic and overseas at any time according to business needs.

能够根据业务需要随时到国内外出差

专业要求：不限