Senior QS Professional
Tianjin, Tianjin, CN
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
Key areas of responsibility 主要工作职责:
- Input to site quality management review, including but not limited preparation of DV, CAPA, QMT, CR, CC, and Q-Case trend reports for management review. 向工厂质量管理评审提供输入信息，包括但不限于提供DV、CAPA、QMT, CR, CC和Q-Case等的趋势报告供管理层审核。
- Support Site self-inspection and support corporate internal quality audit and external inspections including HA inspections at site. 支持工厂自检，支持总部内部审计和包括HA审计在内的外部审计。
- 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 quality management system related training to employees timely. 及时向员工提供质量体系相关培训。
- Monitor quality system key performance indicators. 监控质量体系关键绩效指标。
- Drive or support Quality initiatives。 推动或支持质量部的各种活动。
- Coordinate QS or regulation affairs related issues. 协助质量体系或法规事务相关事项。
- Approve or support approval of quality documents, e.g. SOPs, DV, CR… 批批准或协助批准质量文件，如SOP， DV，CR等。
- Maintain Customer Complaint (CC) handling process in STJ and monitor CC related data. 维护天津工厂客户投诉流程并监控客户投诉相关的数据。
- Organize or support CC related investigation and communicate to stakeholders including external stakeholders like NN BJ affiliate, health authority… 组织或支持CC相关的调查并与相关方保持沟通，包括外部相关方，如NN北京办公室，监管机构等。
Qualifications
- 4-yr (BS) Degree or above 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或以上
- Fluent in written and spoken English良好的英语书写和沟通能力
- Minimum 5 years of experience related to quality in pharmaceutical or medical device manufacturing industry or working in a similar position. 至少5 年制药或者医疗器械制造行业质量相关岗位工作经验。
- Previous experience with quality system, quality assurance, ISO9000, ISO13485, cGMP，EMA and FDA quality system regulation. 熟悉质量体系、质量保证、ISO9000, ISO13485, cGMP法规EMA和FDA质量系统法规。
- Prefer experience of customer complaint handling, or post market surveillance in pharmaceutical or medical device industry.最好有制药或医疗器械客户投诉，上市后监管等经验。
Working at Novo Nordisk
At Novo Nordisk we recognise 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 the communities we operate in.
We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. We are happy to discuss flexible working, depending on the role and subject to business needs.
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.
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.