宜昌招聘

? 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

Professional Experience专业经验:

? Minimum 5 years of experience in IT quality assurance, and/or working in a similar position, thereinto at least 3 years in pharmaceutical industry. 至少5年IT质量保证相关岗位工作经验，其中至少3年医药行业经验。

? In depth knowledge and experience of cGMP requirement, specially for IT related to GMP. 具有深入全面的IT 相关GMP的知识和相关的经验。

? Ability to worked effectively in cross- organizational networks. 具有在跨组织的工作网络中高效工作的能力。

? Has demonstrated ability to deliver high quality results and improve process. 具有改进工作流程、高质量完成工作的能力。

? Able to communicate from operator level to CVP level and as an expert able to convince internal stakeholders on disagreements. 具有良好的沟通能力，下到操作员上至工厂副总裁，当有意见分歧时运用自己的专业意见说服各方以达到意见一致。

? Ability to motivate and lead people in change process. 具有在变革过程中带领和激励员工的能力。

Purpose of the Job 职位目标:

The senior IT QA engineer is responsible for all quality assurance related matters in IT compliance & 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IT质量保证工程师负责诺和诺德天津工厂所有相关IT符合性&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:

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

? Define, implement, maintain and promote IT compliance in Site Tianjin in conformity with NN quality management system requirements and HA requirements & expectations, as well as collaboration on Site Tianjin business process 定义、实施、维护和提升天津工厂IT符合性，使其符合公司质量管理体系要求以及法规的要求和预期，并整合了天津工厂的业务流程。

? Identify and mitigate risks on IT compliance, and to provide advice and conclusion to management team and line of business in all matters related to interpretations and implementation of validation related regulatory requirements in STJ. 发现并降低公司IT符合性风险，在相关的法规要求的解读和执行领域向工厂管理层以及各个业务部门提供专业的意见和解决方案的建议。

? Approve or reject document related to IT: 批准或驳回如下有关IT的文件：

o Non-conformities (e.g. incidents, OOS, FI) 偏差（例如：事故，OOS， FI）

o Validation non-conformities for all process in STJ 天津工厂所有流程的验证偏差

o Change requests 变更

o Periodic System Evaluation reports 周期性系统评估报告

o Qualification and Validation documentation 合格证书和验证记录文件

o 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。

o And other quality related documents 其他质量相关文件

? Ensure that IT associated to validation activities are in control and that process requirements are fulfilled. Ensure inspection readiness at all times. 保证IT系统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。

Senior IT QA coordinates and/or supports the actions necessary to achieve planned results and continual improvement of Quality Management System. 高级IT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。

Senior IT QA also participates in: 高级IT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

? 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。

诺和诺德在中国
诺和诺德是中国市场的领导者，一直以改变为己任。诺和诺德（中国）制药有限公司于1994年成立，二十几年来业务一直保持强劲增长。公司总部设在北京，产品和服务遍及全国所有省、直辖市及中国港澳台地区。截至2017年底，诺和诺德在华员工总数4329人。诺和诺德是在中国建立研发中心的生物制药公司。位于北京的研发中心是诺和诺德全球研发体系的组成部分，致力于与总部合作研发新产品及新生产工艺。诺和诺德在中国的生产厂位于天津，是公司的国际化战略生产基地。公司对工厂提供了大量的资金投入和技术支持，向全球以及中国市场供应产品。诺和诺德在中国的不断发展反映了公司对中国市场的承诺。

Novo Nordisk in China
As the leader in the Chinese market, Novo Nordisk has always been committed to Changing.
Founded in 1994 and headquartered in Beijing, Novo Nordisk’s presence in China has been growing for more than 20 years.Headquartered in Beijing, providing products and services across mainland China as well as Hong Kong, Macau and Taiwan of China. As of the end of 2017, Novo Nordisk employed over 4,329 employees in China.