苏州招聘

Duties
Manages and executes the qualification and validation of equipment, infrastructure (e.g. utilities and support systems) and software to assure quality and stability prior to deployment in commercial environments
Ensures appropriate regulations, guidelines and company policies are followed and applied during all stages of project activities
Responsible for deliverables such as system assessments, validation (e.g., DQ, IQ, OQ, PQ) protocols, commissioning plans, commissioning and validation summary reports, etc., for new functionality, enhancements, changes, maintenance releases, and periodic revalidation
Works with cross-functional teams (e.g. Operations, QA, and Project Management) to evaluate and establish testing milestone and criteria to ensure projects are on schedule and meet quality compliance
Identifies and coordinates activities and tasks required to complete qualification and validation activities including reviews with QA, obtaining signature approvals, executing plans and protocols
Provides training and mentoring related to all aspects of the job to new colleagues
Assists in resolving and documenting technical and project-related issues

Background
3+ years of experience in a regulated environment
Experience in biotech, pharma, and/or medical device is preferred
Bachelor’s degree in a Life Science, Engineering, or related discipline or comparable experience
English reading and writing ability
Technical writing, verbal communication, interpersonal and problem solving skills
Proficient in testing principles, quality systems, engineering design fundamentals, regulatory agency expectations and industry trends is preferred
Expertise in interpretation of applicable regulations and industry guidance documents used in GxP environments is preferred
Ability to assemble, analyze and evaluate data and able to make appropriate recommendations and decisions
Commitment to quality
Able to manage multiple tasks and work independently
Able to manage schedule and budget
Must be customer focused and a team player; experience working with global team is a plus

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。