Senior QA Engineer

Purpose of the Job 职位目标:

The senior QA engineer of validation is responsible for all quality assurance related matters in Validation department, ensuring high compliance with cGMP requirements and internal NN procedures. 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.

The overall success will be measured upon:

1. High efficiency/quality work of process support.
2. Independent capability of process support and problem solving.
3. Good behaviour for high quality mind set, simplicity the process and continuous improvement.

Good co-operation and communication with inside/outside department/site stakeholder with across boundary behaviour.

高级质量保证工程师负责诺和诺德天津工厂所有验证部门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cGMP的要求以及诺和诺德内部程序。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。

工作的成果从以下方面衡量：

1. 高质高效地完成流程支持工作
2. 独立地完成流程支持工作和解决问题
3. 高度的质量意识、良好的行为表现、简化流程以及持续改进

与各个工作相关方良好合作和进行有效沟通。

Main Job Tasks 岗位职责:       

Validation & IT QA has the responsibility and the authority to:                                                       验证及IT高级质量保证工程师被授权负责以下工作：

• Validation committee Chairman 担任验证委员会主席
• Periodic System Evaluation reports 周期性系统评估报告
• Validation Status Summary 验证状况总结
• Qualification and Validation documentation 合格证书和验证记录文件
• Approve or reject: 批准或驳回如下文件：

• Non-conformities (e.g. incidents, OOS, FI) 偏差（例如：事故，OOS， FI）
• Validation non-conformities for all process in STJ 天津工厂所有流程的验证偏差
• Change requests 变更
• Periodic System Evaluation reports 周期性系统评估报告
• Qualification and Validation documentation 合格证书和验证记录文件
• Preventive actions & Corrective actions through the definition of Quality Activities Plan (QAP)           在质量活动计划中定义的预防性活动和纠正性活动。
• And other quality related documents 其他质量相关文件

• Ensure that facilities, equipment, process associated to validation activities are in control and that process requirements are fulfilled. Ensure inspection readiness at all times.                                         保证厂房设施、设备、工作流程等与验证相关事务及活动可控，并且满足所有流程要求。随时准备好接受检查。
• Carry out other Quality, Business, Projects related tasks assigned by the Quality VP or Site Management.    执行工厂管理层及质量副总裁指派的其他质量、业务、项目等相关任务。
• Ensure to take adequate training before handling specific task/approval.                                   在处理特殊任务或批准特殊文件之前确保已接受充分的培训。

  Validation & IT QA coordinates and/or supports the actions necessary to achieve planned results and continual improvement of Quality Management System.                                                                      验证及IT系统质量保证工程师协调并支持必要的活动以达到预期的结果，推动质量管理体系的持续改进。                                                                                         

  Validation & IT QA also participates in:                                                                            验证及IT系统质量保证工程师还要参与以下工作：

• Internal/external audits/inspections and appropriate follow-up 应对内、外部审计及跟进相关工作
• Relevant projects related to production, equipment and facilities 生产、设备及厂房设施相关的项目
• Quality Management Review 质量管理回顾
• Potential and actual recall situations. 潜在的和实际产品召回情况分析。

•  

  QP delegate for validation process, with the responsibility of:

  验证过程的质量授权人代表，有以下职责：

  Be responsible for the process as QP delegate

  作为质量授权人代表对流程负责

  Oversee the responsible process for inspection readiness

  全面负责对应流程的审计完备性

  Escalate the concern to QP

  向质量授权人上报问题

  Drive process improvement together with the group towards N&S

• 与团队一起基于N&S推动流程改进

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.