QA Specialist 质量保证专家

作为中国市场的质量保证专家:

Ensure the products are produced, tested and released in accordance with the relevant requirements, including the regulations, registration files and quality specifications.

确保每批已放行产品的生产、检验均符合相关法规、药品注册要求和质量标准

Participate the escalated deviations according to NN procedures.

按照诺和诺德程序文件要求参与处理上报的偏差

Review the customer complaints before the case concluded.

审核客户投诉的处理

As the QP substitute if QP is not on duty:

Review the APR, including review the Adverse Event report and ongoing stability study result

审核年度产品评估，包括审核不良反应报告和持续稳定性考察结果

Review the Site Master File

审核天津生产厂主文件

Participate the decision to start production in new facility or changes to a facility/production line

参与新设施或改造的设施/生产线开始生产的决定。

Review service level agreement that STJ with Novo Nordisk A/S and other business countries enters into with contract manufactures for bulk drug and finished products.

审核天津工厂与诺和诺德总部和其他业务地区/国家就待包装产品和成品合同生产的服务水平协议。

Approve the critical DV if necessary

如需要批准关键偏差

Approve MA-3,MA-4 CR related with the new products and new equipment/facility

批准MA-3,MA-4涉及新产品和新设备/设施的变更

Approve the specification of products and material

批准产品和物料质量标准

Participate the relevant processes to maintain the QMS as the QA Specialist for Medical products marketed to Chinese Market

作为中国市场的质量专家, 参与维护质量管理体系的相关过程：

Participate the internal audit and inspections

参与内部自检、外部质量审计

Participate the signal process

参与新法规的分析

participate the site QMR meeting

参与质量管理评审

Participate the CAPA/QMT handling

参与质量纠正预防措施/质量趋势的处理

Participate the QRM process, including participate the QRM based QA oversight for the core processes

参与质量风险管理过程，包括结合关键过程QA巡检的质量风险管理

Participate the validation activities, including the QA oversight for the complex validation

参与验证过程，包括复杂验证过程的QA巡检

Participate the product potential recall and actual recall

参与产品召回

International and national complexity and responsibilities as QA Specialist

作为质量保证专家的国际国内综合职责

Ensure compliance with marketing authorization, rules, regulations and requirements regarding quality at site STJ and compliance to EU GMP annex 16 regarding contract manufacture and import to EU

确保遵守营销授权、规则、法规和要求，确保天津生产厂的质量，并符合欧盟 GMP 附录16关于制造和进口到欧盟的规定

Act as counsel in connection with quality issues across all sites

代表天津生产厂质量部门担任相关生产厂质量问题的顾问

Establish and manage agile and compliant processes across AM/FPM and ensure alignment with external requirements and Novo Nordisk interpretation 在整个AM/FPM中建立和管理敏捷且合规的流程，并确保与外部要求与诺和诺德的解释保持一致

In and on behalf of AM QA, efficiently share expert knowledge about and experience in key processes of high complexity and strategic importance

在AM QA内部和代表AM QA高效分享有关高度复杂和战略重要性的关键流程和专业知识和经验。

Provide guidance and advice on cGMP interpretation in Product Supply to all levels of the organisation, including QCVP and SVP levels

为组织的各个层面（包括质量副总裁和高级副总裁级别）提供有关生产供应部中cGMP解释的指导和建议

Recognised as the expert within own field of expertise by various stakeholders and so considered the obvious choice for solving complex problems

被各种利益相关方公认为专业区域的专家，因此被认为是解决复杂问题的优秀人选

Technical responsibilities as QA Specialist 作为质量保证专家的技术职责

Maintain License to Operate. Ensure compliance with cGMP, ISO13485 and ensure audit and inspection readiness, including Training effectiveness, deviations, change requests, SOP updating etc. 天津生产厂的生产许可证的维护：确保cGMP ISO13485的合规性并确保内外审准备就绪

Quality Support to production departments. Make sure that Q KPI’s are fulfilled, balanced with timeliness and lead-time are in control.

为生产厂生产部门提供质量支持。确保质量KPI得到满足，兼顾及时性和交货周期。

Supporting standardization and optimization activities across boundaries

支持跨国标准化和优化业务。

Key member of local Audit and Inspection in site TJ.

作为关键成员支持天津生产厂的质量审计和外部审查。

Participate in the AM Q STJ mgmt.. meetings as a member of the AM Q TJ mgmt. team

作为天津工厂质量管理团队成员，参与例会

Geographic responsibility:

地域职责

Position is geographically placed in Tianjin. QA responsibility in STJ.

该岗位地理位置在天津。质量保证负责天津生产厂。

Interaction with health authorities from countries worldwide as the position is key member of inspections.

与来自世界各国的当局互动，因为该职位是涉及审查的关键人员

Communicate directly with international and national stakeholders (MoC, Clayton, Chartres, DK). This requires strong communication skills and understanding of a variety of different cultures.

直接与国际和国家利益相关者（巴西厂，美国厂，法国厂，丹麦厂）沟通。这需要强大的沟通技巧和对各种不同文化的理解。

Qualifications

Bachelor’s degree or Maste degree in Pharmacy, Biology, Chemistry, or related field.

药学，生物学，化学或其他相关学科本科或说是学位教育背景。

Excellent command of written and spoken English.

熟练掌握英语书面语及口语

Minimum 10 years’ experience from production or Quality area in GMP regulated pharmaceutical industry.

在符合GMP法规的制药企业生产或质量部至少10年以上工作经验

Full of experience in audit and inspection.

丰富的应对审计和检查的经验

Have deep understanding and expertise in regulatory requirements and industry guidelines for validation.

深入了解验证方面的法规要求和行业指南。

Broad experience with quality systems and standards applied by Novo Nordisk.

对于诺和诺德所实施的质量体系及标准有丰富的经验

Living NN Way and Novo Nordisk policies.

对于诺和诺德之道及政策能够有效执行

cLEAN mindset integrated with quality mindset

与质量意识整合的精益管理理念