QA engineer IV
Tianjin, Tianjin, CN
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. 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质量保证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 affair inquiries. 应对内、外部审计和检查，回答法规事务调查和询问。
- Review relevant documents. Release or reject incoming secondary packaging materials and prefilled assembly components etc.
- 审核相关记录。放行或拒绝进厂二级包装材料和预填充组装组件等。
- Oversee facilities, utilities, equipments, materials and operations in the related to Production Support. To monitor the factors that may affect product quality and ensure all of them are in control and fulfil relevant requirements.
- 监督厂务部门相关的厂房，公用设施，设备，物料和流程操作。 监测可能影响产品质量的因素，保证上述项目可控并满足相关要求。
- Manage local supplier by conduct business review, evaluation and audit. 管理本地供应商，对供应商进行业务审核、评估、审计。
- QA batch review and release of durable device 。
- 耐用器械批记录QA审核和放行。
- 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）批生产记录
- Deviation 偏差（DV）
- Customer complain 客户投诉（CC ）
- Change requests 变更 (CR)
- Quality case 质量事件（Q-Case）
- Preventative maintenance plans 预防维修计划（PMP）
- Calibration specification sheets 校准说明书
- Alarm follow-up form 报警跟踪表
- logbook 日志
Qualifications
- 4-yr (BS) Degree in Pharmaceuticals, Engineering or related field
药学、工程学或其他相关领域学科4 年本科教育学士学位
- Fluent in written and spoken English
- 良好的英语书写和沟通能力
- Minimum 3 years of experience in quality assurance, and/or working in a similar position. 至少3 年质量保证相关岗位工作经验。
- Previous experience with ISO9000, ISO13485, CFR21 820 and cGMP is preferable. 最好有ISO9000, ISO13485, CFR21 820以及cGMP相关的经验。
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.