QA Engineer Ⅳ

Purpose of the Job 职位目标:

The responsible area of Validation & Project QA function covers the whole site:

1)All areas that need validation activities, for example, facilities, utilities, equipment’s and IT systems, quality assurance of IT department in Business Support Area; and

2) Quality Assurance for MIT area within QMS;

3) Ensure STJ compliance with internal and external requirements and quality assurance of itself.

验证和项目质量保证职能部门的负责区域覆盖天津生产厂：

1）所有需要验证行为（厂房，公用设施，设备和IT系统）的区域，以及支持区域的计算机系统部门；和

2）QMS范围内MIT质量保证；

3）确保天津工厂符合内外部法规要求以及本职能部门的质量保证。

The main responsibilities and authorities include but not limited to:

· Review and approve documentations:

o Deviation (IT related and HVAC requalification failure related) and implementation of corrective and preventive actions.

o Validation Deviation implementation of defined actions.

o Change requests from IT.

o SOPs (related IT and landscape validation S9.04)

o On-going process verification (OPV)

o Qualification and Validation documentation

o Other IT related documents

· Take active role when needed:

o Authority Inspections and Internal Audit to display STJ compliance level and ensure findings were investigated and handled properly.

o Potential/actual recall to ensure proper investigation and comprehensive evaluations.

o Quality management review to ensure STJ QMS is maintained effectively by adequate resources.

· Apply Device FSC approval from health authority.

· Support BJRA/RAHQ on Device global registration and drug registration in China.

· Maintain Site Master File.

· Maintain manufacturing license

· Get registered specifications from BJRA for API, PPM, and drugs and share with QA and QC functions.

· Maintain relationship with local health authority for routine GMP related communication.

· Drive the implementation of healthcare regulations in STJ.

· Maintain Customer Complaints handling QMS processes to ensure the effectiveness and applicability

· Ensure compliance with external/internal requirements and keep inspection readiness at all times.

· Facilitate Audit/Inspection and drive to close audit/inspection findings.

· Review and approve by Validation QA on behalf of quality head related drug：

o Change requests from IT

o Qualification/Validation protocols and reports.

· Approve Customer Complaints related QMS SOPs by Validation & Project QA senior QA manager on behalf of quality head.

主要职责及权限包括但不限于

· 审核和批准文件：

o 偏差（IT系统相关和空调系统再确认失败相关）及预防和纠正措施的实施

o 验证偏差及相应措施的实施

o IT相关变更申请

o SOP（与IT及S9.04验证相关）

o 正在进行中的工艺确认（OPV）

o 确认和验证文件

o 其他IT相关文件

· 在需要时，积极参与以下行动：

o 外部审计和内部审计，展现天津生产厂的合规水平，确保发现项得到充分和妥善处理。

o 潜在/实际召回，确保其得到了充分调查和全面评估。

o 质量管理评审，确保天津生产厂有充足的资源维护质量管理体系的有效性。

· 向药监机构申请器械自由销售证明。

· 支持北京法规事务/总部法规事务进行医疗器械全球注册，以及药品在中国市场的注册

· 维护工厂主文件。

· 维护生产许可证。

· 从北京法规事务获取原料药，初级包材和药品的注册质量标准，分享给QA和QC部门。

· 维护与当地药监机构日常GMP沟通的良好关系。

· 促进在天津生产厂全面实施医疗法规。

· 维护客户投诉处理质量管理体系流程，确保其有效性和适用性

· 确保符合内部/外部要求，保证随时准备审计的良好状况。

· 协助内外部审计，促进关闭审计发现项。

· 验证质量保证人员代质量负责人审核和批准药品相关:

o IT相关变更申请

o 相关确认或验证方案和报告

· 验证和项目质量保证高级经理代质量负责人批准客户投诉相关质量管理体系SOP。

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.