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QA Associate Director/Director

面议

上海市

刷新时间:2021-03-16

职位描述

Primary Function 主要职能:

Responsible for all R&D Quality Ass**ance activities at Hangzhou including responsible for driving the development of company Policies and Proced**es ass**ing that there is worldwide compliance with company policie***or GCP/GLP/GVP and the laws and regulations governing drug discovery and development in all counties where we study o** products; responsible for all R&D related audits and associated quality processes within the GCP, GLP and GVP Quality Management ****** (QMS).

负责杭州公司R&D所有质量保证相关工作,包括推动公司政策及流程的制定,以确保公司遵守所在开展研发活动国家和地区的法规;开展稽查及确保相应质量体系运行符合GCP,GLP和GVP质量体系**要求。

Major Responsibilities and Duties 主要职责和任务:

1. A full partner with the R&D functional group***y establishing and maintaining a quality- oriented organization that ass**es sustainable compliance with the laws and regulations governing drug discovery and development as well as the validation of computer-based ******s to regulatory standards.

与R&D各职能部门建立全面合作伙伴关系,致力于建立、**质量导向的R&D组织。确保符合药物发现及开发相关法规以及计算机**符合相关**标准。

2. Establish, maintain, standardize, and manage Quality Management ****** (QMS) covering all GxP activities and clinical studies.

建立、**、标准化及**涵盖所有GXP相关活动及临床研究的质量**体系。

3. Ens**es that there is an appropriate and ******atic approach in place for quality approval of documents such as Standard Operating Proced**es, deviations, risk evaluation and management, validation and other quality related records as defined within the QMS

确保合理的及**性的质量保证机制批准QMS相关文件包括:标准*作流程、偏差、风险评估及**文件、认证文件以及其他质量相关文件。

4. Ens**es regulatory requirements and policies are implemented within SOPs as appropriate.

确保相关的法规及政策通过标准*作规程得到很好的执行。

5. Provide Quality Ass**ance (QA) oversight of Discovery, Non-Clinical and Clinical Programs.

对早期发现,非临床及临床项目进行质量保证**。

6. Serve as a subject matter expert for Good Clinical Pract*** (GCP), Good Laboratory Pract*** (GLP)and Good Pharmacovigilance Pract*** (GVP) for Discovery/Non-Clinical/Clinical R&D Project Teams.

作为GCP, GLP及GVP的相关问题专家为相关R&D早期发现/非临床/临床团队提供支持。

7. Develop and manage an internal/external audit program to verify and improve the effectiveness of the quality management ******.

建立及**内部/外部审计计划以验证及改善质量**体系的有效性。

8. Conduct audits to clinical investigational site*****ternal serv*** providers such as clinical research organizations, and non-clinical laboratory et al., ens**ing rojects are conducted in a compliant manner.

开展审计临床研究中心,外部供应商如CRO,非临床研究实验室等,确保实验/试验项目的合规性。

9. Maintain and communicate performance of the QMS via the agreed Quality Key Performance Indicators - to ens**e deviation, Corrective Actions and Pr*****ive Actions et al are handled to a high standard in appropriate timeframe.

通过确定的质量KPI参数来**QMS的执行情况,确保高质量及时的处理偏差、CAPA 等。

10. Schedule and lead Quality Management ****** Periodic Management Review.

组织和领导**层定期对质量****进行评估。

11. Lead the preparation for and actions arising from inspection***y Regulatory Authorities/Notified Bodies, serve as coordinator for onsite inspections.

领导来自**机构或第三方机构的稽查准备及相关行动,作为现场稽查的协调人。

12. Line management/people management to R&D Quality Ass**ance team. Provide trainin***entoring to the junior QA staff.

作为R&D质量保证团队的直线领导,为初级QA员工提供培训及指导。

Qualifications 资格要求:

1. A minimum of a bachelor's degree is require********>本科或以上学历。

2. A minimum of 6 years of QA experience is require********>6年以上质量保证相关工作经验。

3. A thorough understanding and experience with the application of Good Clinical Pract*** (GCP)is require********>对GCP应用有全面了解和经验。

4. Broad based technical knowledge and skills in diverse areas of busines*****: R&D, Clinical Operations, QA, laboratories, etc.) is preferre********>期望在多领域有广泛的业务知识与技能,如R&D,临床**,QA,实验室等。

5. Ability to effectively negotiate with and influence project teams is preferre********>期望拥有有效的谈判能力和对项目组的影响力。

6. Strong verbal and written communication skills are require********>较强的口头及书面沟通技巧。

其他要求

  • 10人
  • 研发总监/研究院院长

公司介绍

诗迈医药猎头是一家专业从事医药行业猎头服务的科技型企业,总部位于杭州,下属有上海、南京、广州、武汉等多家分公司,同时自主开发国内领先的猎头办公系统及医药人才网站,全面致力于海内外制药、生物、医疗、器械等行业线上线下人力资源整合。
公司与全国各地研发企业、生产企业及销售经营等企业及业内同行建立了良好互动平台,在欧、美、日等国家建立了海归引进平台,同时积极开展医药高等院校公益系列讲座,搭建了以人力、企业为主体的立体化咨询服务网,为医药企业人才队伍建设发挥了积极重要作用,为很多医药企业解决了高端人力之困。

所在城市:
所任职位:
BP

企业信息

名称:
诗迈医药猎头
行业:
制药.生物
性质:
中外合营(合资/合作)
规模:
50-99人

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