工作职责:

This position is the Corporate Quality Authority for the CMO management. Supporting product release to makesure product manuafactured compliance with cGMP.

Support to provides strategic quality programs to Edding Pharma(EDP) to ensure that CMO management procedures, regulatory quality and compliance standards and guidance are implemented and are sustainable, audit, evaluate, approve and routine manage CMO accordingly.

As Marketing Authorization Holder, support to monitor quality and compliance activities in CMO to ensure that all quality activities operations are in compliance with cGMP’s(China/EU), Regulatory standards(China/EU) and Edding Pharm Policy, to make sure the quality of EDP finish product is safe for patients.

Supporting for the investigation and resolution of all quality issues handling in CMO and for interacting with the relevant stakeholders on such issues.

Keep good relationship with CMO.

? Ensures CMO related quality issue investigated and closed prior to product release.

? Quality issue handling for the investigation and resolution of all quality issues in CMO, includes deviation/change control/OOS/OOT… relavent to EDP.

? Raw data review for manufacturing process, includes batch record, testing report, release certificate for bulk and finish product.

? Support CMO QP for finish product release and make sure finished product released in compliance:

o Ensure all deviations are closed

o Ensure all Changes are closed, if relevant

o Review analytical data

o Review batch records

o Sterility Assurance - For each parenteral product, batch parameters related to Sterility Assurance are reviewed

? Make decision to approve or reject product.

? Support to develop and approve Quality Agreement with CMO and ensure Quality Agreements are in place

? Participate/follow up:

o Deviations, change controls, stability program, performance review.

o Development of MBR, Process Validation Protocols and Reports, in conjunction with Technical department.

? Other jobs which may be assigned.

任职资格:

? Bachelor degree in Pharmacy, Chemistry, Biology, Microbiology, Biochemistry, Engineering or similar related disciplines.

? A minimum of 3 years previous experience is required in positions of increasing responsibility within Quality Assurance or other relevant quality functions within the pharmaceutical industry.

? Experience in logistics & supply operation, desirable.

? Demonstrated ability to influence stakeholders and proven record in driving changes initiatives.

? Strong communication and interpersonal skills to guide groups.

? Adaptable to work priorities in response to complex or rapidly changing environment.

? Deliver results with limited resources.

? Ability to define, evaluate, recommend and implement improvement opportunities in the regulatory compliance areas.

上班地址：桑田街218号生物产业园

亿腾医药成立于2001年9月，主要是在全球范围内寻找适合中国医药市场的医疗产品。亿腾的服务领域包括：全球产品引进、产品注册、产品定价、招标、营销、国际医药贸易、适应症开发和建设医药合作平台。
一直以来，亿腾医药将业务的重点放在重症医疗、生存质量领域；秉持以客户为导向的原则，以卓越的执行力和创造性的操作，为合作伙伴提供有针对性的服务；不局限于产品，更注重长期战略合作。
作为中国医药行业“专业营销”领域的领导者。公司更加注重“以人为本，追求卓越”的企业文化建设，通过精英学院，讲师培训，医药营销专业知识培训，完善的福利制度等力图将亿腾打造成中国医疗市场专业人才发展宏图，实现梦想的平台。
目前亿腾医药健康运营，快速发展，已经聚集了医药行业营销精英逾800人。自上而下一直贯彻着一个理念：亿腾要成为药品生产企业开拓中国市场的合作伙伴和医疗机构及临床医生使用药品的可靠助手，亿腾的每一个成员都会是决定此目标成败的关键。
专业团队成就专业品牌，亿腾在全体成员的合作下，努力成为中国最强大的医药产品营销专家！
公司现因业务发展需要，招聘如下职位。欢迎各界精英应聘。一经聘用，公司将提供有竞争力的回报和广阔的发展空间!
公司官网：www.eddingpharm.com