QA Area Specialist 质量保证区域专家
Tianjin, Tianjin, CN
Education Background: 教育背景
• Bachelor or above 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
• 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 10 years of experience in quality/GMP field, at least 5 years in related validation professional position or leader position. 至少8年质量相关工作经验，其中至少5年质量合规专业岗位或者质量合规团队领导岗位工作经验
• Deep understanding of Annex I and isolator aseptic control, experience with setting up new line/facility is preferred. 深入理解附录I和隔离器无菌控制，有新建生产线/设施经验者优先。
• Have deep understanding and expertise in regulatory, GMP, ISO and compliance. Broad experience with quality system management. 丰富的法规、GMP、ISO、合规方面的专业知识，以及质量管理体系相关经验。
• Full of experience in audit and inspection and good interaction with health authorities. 丰富的应对审计和检查的经验和良好的与监管机构沟通的能力。
• High level of communication skills and culture understanding. 高超的沟通技巧和对文化的理解能力。
• Ability to influence department/process performance. 具备影响负责部门/流程能力
Purpose of the Job 职位目标:
The project QA Area specialist is technical lead of all GxP quality related broad and complex matters, ensuring compliance with NMPA(National Medical Products Administration), EU GMP and NN internal procedures requirements.
Assist project management to make right decision from quality point of view. Support other QA colleagues with compliance and technical knowledge. Support stakeholders when they consult about quality and compliance questions.
The position Requires in-depth knowledge and experience of Aseptic production knowledge, especially isolator technology.
The project QA area specialist is also responsible for driving robust Validation system and ensuring high Validation compliance level across different areas in FFEx project by applying SRV concept.
The blow tasks are primarily related to FF expansion project but may be extended to other QA responsible areas when line management judges necessary.
• Act as Aseptic production QA expertise to identify and mitigate GMP compliance risks during FFEx project phase, and to provide advice and conclusion to management team and line of business in all matters related to interpretations and implementation of GMP in project.
• Input and Ensure program quality strategy implementation in STJ.
• Risk Assessment associated with validation process as well as handling of Validation Deviations.
• Across Work with program and FFEx other site QA expert to share and implement best practice, define and solve issues across site,
• Provide oversight on FFEx project.
• Drive quality and compliance related projects, that including:
o GMP assessment
o Supplier supervision
o Other global projects related to quality and compliance
• Provide quality and compliance related input and make decisions on quality and compliance related issues.
• Coach QA employees within and outside of the quality assurance department.
• Review and approve operational documents requiring QA approval, including but not limited to:
o Standard operating procedure (SOP) 标准操作规程
o Validation document 验证文件
o Change requests 变更 (CR)
o Preventative maintenance plans 预防维修计划（PMP）
o Calibration specification sheets 校准说明书
o logbook 日志
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants.
At Novo Nordisk, we're not chasing quick fixes – we're creating lasting change for long-term health. For over 100 years, we've been driven by a single purpose: to defeat serious chronic diseases and help millions of people live healthier lives. This dedication fuels our constant curiosity and inspires us to push the boundaries of what's possible in healthcare. We embrace diverse perspectives, seek out bold ideas, and build partnerships rooted in shared purpose. Together, we're making healthcare more accessible, treating and preventing diseases, and pioneering solutions that create change spanning generations. When you join us, you become part of something bigger – a legacy of impact that reaches far beyond today.