工作职责:

? Conduct inspections/audits of studies, facilities, specific, systems and vendors, report observations to management, and maintain complete inspection/audit files on assigned studies/projects.

? Schedule/conduct inspections of QA activities.

? In case of multisite, report inspection report to lead QA.

? Audit study protocols and final reports and associated amendments and prepare QAU statements for final reports within all GLP areas.

? Interact with all levels of management of all GLP/CNAS or other regulated areas.

? Schedule/conduct internal audit and survillian audit per CNAS.

? Interact with clients during visits/audits.

? Assist in the preparation of QA audit techniques, forms and checklists and prepare and review Quality Management System Document and quality processes.

? Interact with regulatory authorities during inspections.

? Provide advice/consultation on QA and regulatory issues and quality management systems.

? Support/audit computer validation projects and activities.

? Review Chinese/English documentation or SOPs.

? Review line function SOPs for compliance with regulations.

? May review and approve SOPs for compliance with regulations.

? Conduct internal GLP/Quality training programs.

? Maintain QA records and support QA trend analysis.

? Review and approve QA documents including but not limited to audit reports, QA statements and QA SOPs (if applicable).

? Sign for QA Management review of protocols and reports and associated amendments, as necessary, for Chinese submission.

? Act as designee for QA management for designated responsibilities.

任职资格:

? Degree in Natural Sciences or comparable related experience

? At least five years working experience in R&D, pharmaceutical or medical device industries, including auditing/inspecting against regulatory standards and/or work in GLP/ISO/CNAS regulated laboratory

? Good interpersonal and communication (written and oral) skills

? Good understanding both written and oral of English language

? Understanding of regulatory (GLP/ISO/CNAS) requirements

? Ability to comprehend scientific and mathematical terminology and calculations

上班地址：吴中大道1318号

苏州药明康德成立于2006年10月，是药明康德全资子公司，该设施面积达三万多平方米并且目前向全球客户提供符合GLP标准的遗传毒性实验服务，并通过了AAALAC的国际认证； SFDA的GLP认证；欧洲OECD的GLP认证；是全球唯一一家通过全面资质认证的药物安全性评价中心。
同时，苏州药明康德拥有众多获得资格认证的毒理学家和病理学家们，能够为国内外客户提供包括大小动物的急性毒性、长期毒性、药代/毒代、生殖毒性、安全性药理、遗传毒性等药物安全性评价项目以及体内外药物筛选、药理药效研究等临床前安全评价研究服务。