上海招聘

Job Opening: QA Manager

Key accountability:

· Responsible for set up, implementation and maintenance of cGMP system. cGMP系统的建立，实施和维护。

· Responsible for release and reject of final product, intermediate, raw materials and packing materials, responsible for process water and environmental monitor data review and release. 负责对成品、中间体、原辅料和包装材料的审核，以及工艺水和环境监控数据的审核放行。

· Responsible for review and approve the specification of final product, intermediate, raw materials and packing materials. 负责审核及批准成品、中间体、原辅料和包装材料的规格。

· Responsible for review and approve master BPR. 负责审核及批准主批生产记录。

· Responsible for review and approve the rework and reprocess protocols. 负责审核及批准返工和再加工草案。

· Responsible for review and approve the deviations, changes related to the product quality. 负责审核及批准与产品质量相关的偏差处理和变更申请。

· Responsible for review and approve the protocol and reports of stability testing for key raw materials, intermediate and final products. 负责审核及批准主要原辅料、中间体和成品的稳定性试验的方案和报告。

· Responsible for review and approve the annual product quality review of intermediate, API and drug product. 负责审核及批准原料药、中间体和药品等的年度质量回顾报告。

· Responsible for review and approve the VMP, qualification and validation protocols and reports for the new established facility. 负责新建厂房验证主计划、确认和验证方案及报告的审批。

· Coordination of internal and external quality audits, approve and monitor the implementation of CAPA.负责公司内外质量的审计工作，监控纠正措施和预防措施系统的实施。

Requirements:

· Good understanding of GMP regulation and guidelines in SFDA, FDA and EU. 熟悉SFDA, FDA and EU相关的GMP法规和指南。

· Good understanding of Quality System regulations and requirements and ability to assess and implement improvements to the existing system.对质量系统的法规和要求有较好的了解，能对现有的系统做出改进。

· Good understanding of facility, utility and equipment qualification, process validation, cleaning validation. 对厂房、公用设施和设备确认、工艺验证、清洁系统验证等有较好的了解。

· Superb organization, communication and teamwork skills and strong interpersonal skills to be able to effectively interact within multidisciplinary groups. 优秀的组织和沟通能力、团队合作精神以及良好的人际关系，能有效地与不同部门进行沟通。

· More than 5 years' experience in pharmaceutical manufacturing and quality management, a strong background in fermenation API and injectables manufacturing is most preferred. 五年以上制药生产和质量管理经验，有发酵原料药和注射剂生产经验者优先。

Education & Language:

· Bachelor degree or above; majored in chemistry, analytical, pharmaceutical engineering or related. 本科以上学历，化学或制药相关专业。

· Good command of English, both in oral and written. 优秀的听说读写能力。

Qualified Candidates, pls submit your CV to: lfyang@shangpharma.com

上海睿智化学研究有限公司成立于2002年，是一家世界领先的科研外包服务机构(CRO)，秉承着创新驱动、客户至上的服务理念，致力于为全球制药公司和生物技术公司提供全面且高品质的新药研发服务。
公司业务涵盖了抗体早期研发、小分子早期研发、药理药效、药代药动及早期毒理、生物药CMC、化药CMC、临床样品生产等新药研发各环节，为客户提供整合一体化的新药研发外包服务，已经服务过的国内外制药企业和生物医药技术公司1000余家，其中包括全球排名前20位的医药和生物技术企业。

公司在全球设立了6个办事处，专职研发人员2000人，海归科学家150人，拥有大规模最先进的科研、办公设施、实验动物设施、cGMP级别的公斤级实验室以及医药中间体生产设施。公司通过坐落于张江、奉贤、启东、成都和南旧金山五个重要研发基地持续不断为来自全球范围内客户长期提供优质的服务。