苏州招聘

KEY RESPONSIBILITIES

1.Conduct inspections/audits of studies, facilities, processes, systems and vendors, report observations to management,both test facility and line/study directors, and maintain complete inspection/audit files on assigned studies/projects。

2.Schedule/conduct inspections of QA activities

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

4.Audit study batch records, final reports, certificates of analysis and associated amendments within all GMP areas

5.Interact with all levels of management of all GLP and GMP areas

6.Interact with clients during visits/audits

7.Assist in the preparation of QA audit techniques, forms and checklists and prepare and review QA SOPs and quality processes

8.Interact with regulatory authorities during inspections

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

10.Support/audit computer validation projects and activities

11.Review Chinese/English translated documentation or SOPs

12.Review SOPs for compliance with GLP and GMP regulations

13.Conduct internal GLP/Quality training programs

14.Maintain QA records and Master Schedule and implement and support QA trend analysis

15.Act as QA Document Administrator or deputy as designated

16.Act as QA SOP or Training Coordinator as designated

17. Act as Deputy for Senior Manager for designated responsibilities

MINIMUM REQUIREMENTS

1.Degree in Natural Sciences or comparable related experience

2.Experience in auditing/inspecting against regulatory standards and/or work in a GLP and/or GMP laboratory

3.Good interpersonal and communication (written and oral) skills

4 Good understanding both written and oral of English language

5.Quality driven, analytical, detailed oriented mindset

6.Understanding of regulatory (GLP/GMP) requirements

7.Ability to comprehend scientific and mathematical terminology and calculations

苏州药明康德成立于2006年10月，是药明康德全资子公司，旨在在总公司不断成熟的技术能力及不断强大的经济实力的基础上，开拓一个完全不同于上海药明康德的全新领域,为国内外新药开发提供高端药物非临床研究评价服务。

苏州药明康德已建成面积达三万多平方米的药物安全评价研究中心。该研究中心目前向全球客户提供符合GLP标准的遗传毒性实验服务，并通过了国际实验动物评估认证管理委员会（AAALAC）的国际认证；中国食品药品监督局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。公司在2010年下半年开始提供符合GLP标准的一般毒理研究服务，并通过中国SFDA和欧洲OECD的GLP认证；2013年将提供全面的临床前安全评价研究服务。

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（包括猴、犬）小（包括啮齿类、家兔）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。

以新药研发及安全评价服务为主要业务，苏州药明康德将不断增强其研发实力，扩宽其服务领域，为将药明康德打造成全方位、一体化的药物研发服务平台而努力。

我们欢迎各地英才的加盟，与药明康德一起，发展和进步。药明康德将为员工提供良好的职业前景和众多的培训机会以及有竞争的薪资福利。