上海相关职位： 蛋白表达纯化研究助理 GMP细胞培养工程师 GMP蛋白纯化工程师 生物分析研究员（结构与活性分析） 医药代表 细胞免疫治疗研发人员 新药工艺创新研发实验人员 项目管理 信息学研究员 生物药研发QA专员
周边城市招聘： 上海 浙江 安徽 广东 山东 河北 重庆 北京 江苏 湖南
企业入驻日期： 2017-11-09
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5-7年经验 -
招1人 -
11-09 发布
职位描述
职位描述： Job Purpose (State in one sentence the overall objective of the job)Responsible for Investigational Medicinal Product (IMP) release at Country Pharma Organiza-tion (CPO) for the studies conducted by CPO GenMed and Oncology to ensure that local IMP release and control process are in compliant with the regulatory requirements, Good Clinical Practice (GCP) and Good Manufacture Practice (GMP), together with the other units in CPO such as Development GenMed, Oncology, DS&E, DRA and MA.Major Accountabilities (Describe the main results of the job to be achieved )1.Review of batch records for cGMP compliance2.Set-up activities to facilitate efficient working and effective partnerships with external groups3.Communicates with Packaging/ Warehousing personnel and coordinates timely verifica-tion of shipping orders4.Recognizes problems or delays and takes action to prevent or address issues5.Provides expertise and resolves issues6.Ensure local IMP release and control process is in line with relevant global SOPs. And implement local IMP release and control process relevant SOP development, if needed.7.Conduct regulatory required documents review prior to IMP release to country and sites, and during the study when any regulatory required documents changed/amended8.In charge of authorizing IMP technical release9.Support audit and inspection in the area of IMP management of clinical development activities. Determine root causes and develop corrective and preventive actions (CAPA) and follow up till CAPA implemented on all major and critical audit findings10.In cooperation with other QA Units to ensure analysis, assessment and resolution (includ-ing CAPAs where indicated) of issues in common interfaces11.Participate in PH Dev QA investigation activities, as appropriate12.Provide support to CPO clinical study operation in GMP compliance related activitiesIdeal Background (State the preferred education and experience level)Education (minimum/desirable):Minimum: BS Degree in Life Sciences or related fieldsDesirable: Advanced degree in Life Sciences or related fields (MS)Languages: Chinese and English fluent in speaking and writingExperience:1.Min. 5 years experience in the pharmaceutical industry in a relevant field such as compliance, quality assurance, clinical development or a directly related area2.knowledge and experience of product release or data release preferred3.Ability to negotiate and communicate4.Good knowledge of GCP and/or GMP5.Good knowledge of drug development 职能类别： 药品生产/质量管理
联系方式
上海市浦东新区张江高科技园区金科路4218号
公司信息
北京诺华制药有限公司开发、生产和销售治疗多种疾病的创新处方药，涵盖的疾病领域包括：心血管、内分泌、肿瘤、抗感染、风湿疼痛及骨质疏松、移植免疫、中枢神经以及眼科。北京诺华制药曾获得“***雇主”和“最负社会责任的企业”等殊荣。 “诺华”中文取意“承诺中华”，即承诺通过不断创新的产品和服务致力于提高中国人民的健康水平和生活质量。北京诺华制药成立于1987年，总部设在北京，隶属于瑞士诺华公司。 诺华公司致力于为患者及社会提供创新医药保健解决方案，以满足其日益变化的健康需求。2011年，集团持续经营业务实现净销售586亿美元。集团研发投入约为96亿美元（去除减值及摊销后为92亿美元）。诺华集团总部位于瑞士巴塞尔，业务遍及全球140多个国家和地区，拥有124,000位全职员工。诺华集团立足在中国的长期发展，重要战略投资包括位于上海的综合性生物医学研发中心，以及位于北京昌平的制剂生产工厂和江苏常熟的原料药生产工厂。如需更多信息，敬请登录公司网站http://www.novartis.com和http://www.novartis.com.cn。
