Sr. QA Engineer

Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment.
Apply now and join Novo Nordisk.
Together we can create life-changing innovation.
Together we can make it happen.
The position Provide quality and compliance related input and make decisions on quality and compliance related issues.
Related Validation documents approval, including IT functional and non-functional qualification for facility and equipment 相关验证文件的批准，包含仪器设备和设施的相关 IT 功能性和非功能性验证。 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.
Handle and answer internal and external (authority) audits and regulatory affair inquiries.
Review and approve operational documents requiring QA approval, including but not limited to:
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 Change requests 变更 (CR) IT incident IT 事件 IT Periodical System Evaluation IT 系统阶段性回顾 Qualifications 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 Minimum 5 years of experience in Pharmaceuticals industry ， 3 years quality assurance, and/or working in a similar position is preferred.
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。 IT/OT related working experience is preferred IT 和自动化相关经验优先 Previous work experience related to lab CSV is preferred.
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.
Good knowledge on regulatory requirements and expectations of cGMP from NMPA and EU especially for IT 和 automation related part.
IT 和自动化相关的部分。 Good communication skill and be able to convince internal stakeholders on disagreements.
Working at Novo Nordisk At Novo Nordisk we recognise that it is no longer good enough to aspire to be the best company in the world.
We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.
We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and the communities we operate in.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
We are happy to discuss flexible working, depending on the role and subject to business needs.
Are you motivated by driving innovation for the life-changing benefit of patients? Are you ready to help transform the treatment paradigm for a broad range of chronic diseases that currently rely on injection-based therapies? Then this is your moment.
Apply now and join Novo Nordisk.
Together we can create life-changing innovation.
Together we can make it happen.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world.
We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures.
We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in.
Together, we’re life changing.
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