This listing was posted on Novo Nordisk.
QA area specialist
Location:
Tianjin
Description:
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 Set up project quality management system in conformity with health authority’s requirements, cGMP and NN quality management system. Drive operation readiness with program quality, to ensure standardization implementation across sites. Act as GMP compliance expert to identify and mitigate GMP compliance risks, and to provide advice and conclusion to management team and line of business in all matters related to interpretations and implementation of GMP in STJ. Plan, coordinate and Active participate internal and external audit. Support relevant areas to plan and prepare inspections and audits. Establish good and trustful relationship with the inspectors. Facilitate the process and ensure right understanding of discussions, requests and answers during inspections and audits. Effectively check on major actions afterwards. Plan and organize GMP self-inspection throughout project phase, perform periodic process confirmation of the CQV document. Plan, coordinate and follow up on project GMP Review. Report quality status throughout the project to management including potential quality issues. Ensure that all unit SOPs within the process comply with QMS and are technically and practically workable Verify readiness for audit and inspections and be ready for process presentations within own unit and process Coach and support Supplier quality system optimization to fulfill NN’s requirement. Coach QA employees within and outside of the quality assurance department. Drive quality, RA and compliance related tasks, that including: GMP approval from health authority HA communication and coordination with BJ, HQ RA Other global projects related to quality and compliance Review and approve operational documents requiring QA approval, including but not limited to: Standard operating procedure (SOP) 标准操作规程 Change requests 变更 (CR) Project Quality Plan logbook 日志 Qualifications Bachelor or above 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 Fluent in written and spoken English 良好的英语书写和沟通能力 Minimum 10 years of experience in quality/GMP field, at least 5 years in related validation professional position or leader position. 、 至少 8 年质量相关工作经验，其中至少 5 年质量合规专业岗位或者质量合规团队领导岗位工作经验 Have deep understanding and expertise in regulatory, GMP, ISO and compliance. Broad experience with quality system management. 丰富的法规、 GMP 、 ISO 、合规方面的专业知识，以及质量管理体系相关经验。 Full of experience in audit and inspection and good interaction with health authorities. 丰富的应对审计和检查的经验和良好的与监管机构沟通的能力。 High level of communication skill and culture understanding. 高超的沟通技巧和对文化的理解能力。 Ability to influence department/process performance 具备影响负责部门 / 流程能力 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.
Company:
Novo Nordisk
Posted:
June 14 on Novo Nordisk
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