KEY RESPONSIBILITIES

Description ·

? Conduct audits of lab data, laboratories, systems, and vendors.

? Report observations to management

? Schedule/conduct inspections of QA activities.

? Schedule/conduct internal audit.

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

? Interact with clients and regulatory authorities/notifed body during inspections.

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

? Review Chinese/English documentation or SOPs.

? May review and approve SOPs for compliance with regulations.

? Implement quality training programs and conduct training.

? Maintain QA records and support QA trend analysis.

? Review and approve report for product release.

MINIMUM REQUIREMENTS

? 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 related working experience in quality mangament sytem, such as ISO9001.

? Good interpersonal and communication (written and oral) skills

? Bilingual in speaking and writing (Chinese and English)

? Understanding biotechnology and biological technical aspects.

? 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。