Senior QS Professional

3 months ago


Tianjin, China Novo Nordisk AS Full time

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。
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