CPO Dev Quality Manager 上海

月薪： 30-40万/年

该公司所有职位
  • 5-7年经验
  • 本科
  • 招1人
  • 11-09 发布

职位描述

职位描述： Job Purpose:Is responsible for Good Clinical Practice (GCP) and Good Pharmacovigilance Practice (GPvP) oversight and for assuring the quality and compliance of Development and Medical Affairs (MA) projects, products and programs (Phase I through Phase IV). Ensure in direct collabo-ration and partnership with the CPO Medical Department (including GenMed, Oncology, DS&E, DRA and MA) the implementation of the Novartis Quality Manual and Quality Man-agement System in the CPO Medical Department to achieve a high level of quality and com-pliance.Major Accountabilities:1.Implement and maintain the local Quality System in the areas of GCP and GPvP, in ac-cordance with the Novartis Quality Manual and the CPO Quality Plan.2.In cooperation with local DRA and DS&E, keep abreast of regulatory requirements, and update local management and Pharma Development MA/CPO QA on the possible rami-fications of regulatory changes and impact to Clinical Development, MA and PV process-es.3.Conduct proactive in-process quality and compliance review through monitoring of ade-quate Key Quality Indicators (KQIs) and assure that gaps are addressed appropriately in order to mitigate risk.4.Conduct vendor assessment and/or qualification visits for locally outsourced clinical de-velopment, MA and pharmacovigilance (PV) activities. Ensure the ESP selection process properly followed at the CPO.5.Partner with Pharma Development QA in the preparation, execution and follow-up of audits on clinical development activities. Together with the auditees, determine root causes for country-specific major and critical audit. Verify that appropriate corrective and preventive actions are implemented on all major and critical audit findings.6.In cooperation with the local GMP QA Unit ensure analysis, assessment and resolution (including CAPAs where indicated) of issues with common interfaces.7.Participate in PH Dev QA investigation activities, as appropriate.8.Ensure, where appropriate, interface/communication with authorities for any GCP/PV related activity (e.g. local Health Authority [HA] inspections).9.Ensure CPO readiness for all GxP regulatory inspections.10.Provide support prior to, during and after HA inspections of the CPO, investigational sites or external service providers, as applicable, together with the Novartis inspection lead. Ensures that responses to local Health Authorities have been submitted, commitments have been met and relevant CAPs have been completed /closed.11.Ensure conduct of adequate training at the CPO for all GCP and GPvP activities by defin-ing, planning and supporting training activities.12.Ensure that the clinical and PV computerized systems are adequately identified during the High Level Risk Assessment for GXP relevance to enable their validation where re-quired.Ideal Background:Education (minimum/desirable):Degree in Life Sciences or related fieldsLanguages:English fluent in speaking and writing.Experience:Min. 5 years experience in the pharmaceutical industry in a relevant field such as quality assurance, clinical development or a directly related area 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。

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