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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 Assurance activities at Hangzhou including responsible for driving the development of company Policies and Procedures assuring that there is worldwide compliance with company policies for GCP/GLP/GVP and the laws and regulations governing drug discovery and development in all counties where we study our products; responsible for all R&D related audits and associated quality processes within the GCP, GLP and GVP Quality Management System (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质量体系管理要求。

Major Responsibilities and Duties 主要职责和任务:

1. A full partner with the R&D functional groups by establishing and maintaining a quality- oriented organization that assures sustainable compliance with the laws and regulations governing drug discovery and development as well as the validation of computer-based systems 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、维护质量导向的R&D组织。确保符合药物发现及开发相关法规以及计算机系统符合相关监管标准。

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

建立、维护、标准化及管理涵盖所有GXP相关活动及临床研究的质量管理体系。

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

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

4. Ensures regulatory requirements and policies are implemented within SOPs as appropriate.

确保相关的法规及政策通过标准操作规程得到很好的执行。

5. Provide Quality Assurance (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监督。

6. Serve as a subject matter expert for Good Clinical Practice (GCP), Good Laboratory Practice (GLP)and Good Pharmacovigilance Practice (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 system.

建立及管理内部/外部审计计划以验证及改善质量管理体系的有效性。

8. Conduct audits to clinical investigational sites, external service providers such as clinical research organizations, and non-clinical laboratory et al., ensuring 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 ensure deviation, Corrective Actions and Preventive Actions et al are handled to a high standard in appropriate timeframe.

通过确定的质量KPI参数来维护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 System Periodic Management Review.

组织和领导管理层定期对质量管理系统进行评估。

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

领导来自监管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 Assurance team. Provide training/mentoring 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 required.

本科或以上学历。

2. A minimum of 6 years of QA experience is required.

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 Practice (GCP)is required.

对GCP应用有全面了解和经验。

4. Broad based technical knowledge and skills in diverse areas of business (ex: R&D, Clinical Operations, QA, laboratories, etc.) is preferred.

期望在多领域有广泛的业务知识与技能,如R&D,临床运营,QA,实验室等。

5. Ability to effectively negotiate with and influence project teams is preferred.

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 required.

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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