QA Engineer III

3 months ago

Tianjin, China Novo Nordisk AS Full time

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。 QA batch release as authorized qualification person by Qualified Person when need. 在需要时作为被授权的 QA 执行产品批次放行。 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 Non-conformities 偏差（ NC ） Customer complain and internal complain 客户投诉和内部投诉（ CC and IC ） Change requests 变更 (CR) Quality activity plans 质量活动计划（ QAP ） 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 Annual product review (APR) 年度产品回顾 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。 Good knowledge on regulatory requirements and expectations from SFDA 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 work 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

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