长沙招聘

职位描述：
? Build and maintain robust quality program that will effectively support clinical and commercial manufacturing operations.
? Conduct ongoing evaluations of quality programs, systems and initiatives to assure that product quality standards and regulatory compliance are achieved.
? Establish and maintain a robust quality program that will effectively support the various phases of drug development, Phase 1 through phase 3, as well as commercial manufacturing.
? Interpret Regulatory Authority regulations, guidelines and policies. Utilize internal audits and quality compliance assessments programs to improve compliance processes and procedures.
? Direct the review and approval of the Quality Manual, Quality Policies, Protocols, SOPS, Batch Records, Test Methods, Raw Material Specifications, and Annual Product Reviews and CAPAs.
? Ensure that manufacturing processes, equipment, facilities and systems are validated and that a robust Change Control system and procedures are developed and maintained to meet worldwide regulatory standards.
? Develop and execute Site QA operating and capital budgets and manage department efforts to control costs within approved levels.
? Provide leadership and managerial oversight to the quality department. Develop staff and work closely with them to ensure that a consistent approach is taken in evaluation and resolution of quality issues.

Requirements
? BS degree in a scientific discipline (i.e. Chemistry, Microbiology, Chemical Engineering).
? A minimum of 10 years experience in the pharmaceutical industry.
? Good interpersonal and problem solving skills.
? Must have a quality background from the biotechnology/pharmaceutical industry with GMP experience and a successful track record in quality within FDA and/or EMA regulated environment.
? Demonstrated leadership in cross-functional and culturally diverse team settings.
? Develop and implement effective Development QA programs aligned with corporate strategic initiatives and business goals. 举报 分享

上海恒瑞医药有限公司系江苏恒瑞医药股份有限公司的全资子公司，注册资本7200万元，前期建设投资1.8亿元。公司设位于上海闵行经济技术开发区内，其中研发中心占地10053.53平方米，于2004年5月投入使用。在科研开发方面，公司将瞄准国际先进水平，建立科研基础平台，积极拓展新药研发领域，增加产品剂型，填补国内空白，参与国内国际市场竞争，提高民族医药工业水平。整个研发中心致力于创新药物的发现，以极大的热情向社会提供以科研开发为基础，适合市场需求的高科技医药产品。

为什么要选择上海恒瑞？为什么上海恒瑞一定成功？

***，我们拥有雄厚的资本，决意发明新药，并且已作巨额投资；第二，我们已有丰富的临床和市场发展经验，从实验发明到投入市场的时间大量减少；第三，有能力从目标化合物设计合成，体外体内筛选，药代毒理，药理到GMP生产完全自办；第四，我们拥有一支经验丰富的新药发展团队，融入其中的每位员工都可以增加新药发明过程的经验；第五，我们聘请***的人才，采用先进的生物工程管理方法，以工作表现为基础的薪金奖金制度、活动工作时间以及无上限研究级别升级；第六，我们拥有先进的实验设施—无任务上限的Scifinder的化学信息库等，我们拥有绝对无烟的工作环境，而且先进的实验设备也为我们创造了一个无噪音、无气味的健康环境；第七，我们从事的是真正的有知识产权的新药研发，而不是生产中间体。

Discovering drugs not making intermediates

Shanghai Hengrui Pharmaceuticals Co. Ltd. is a fully integrated drug discovery company with marketed products well funded by a top Chinese pharmaceutical company dedicated to discovery of IP protected New Chemical Entities (NCEs). We are conveniently located in Minhang Economic Zone, 30 minutes from the vibrant Shanghai downtown and occupy a new 10,000 square meter. laboratories equipped with state-of-art instruments. We are currently recruiting scientists in all areas of drug discovery.

We offer a locally competitive compensation and benefits package and provide a highly interactive, open, challenging, smoke-free and campus-like environment. We have also adopted a performance based award system and created a scientific ladder for dedicated and motivated individuals to grow within the company. If you are interested in joining this new drug discovery revolution in China, please forward your resume to Miss Hong (career@shhrp.com) for immediate consideration. Applicants from other areas of drug discovery are also invited to send in their CVs.