China Pharma R&D Quality & Compliance Specialist招聘_西安杨森制药有限公司最新招聘信息-猎才医药网

职位描述

Responsibility：Quality ProcessesProcess, systems and documentation· Support the local impact assessment of global R&D procedural documents and, if applicable, support development and management of associated local procedural documents· Support to take oversight for local procedural documents in close collaboration with functional owners in China R&D/SAF andBRQC process and developmentTraining and knowledge management· Support onboarding of new hires to provide general onboarding training package· Coordinate local workshops to support QMS and compliance awareness, Lessons Learned, etc.· Provide advice regarding SOP, system and GxP(GMP excluded) questions· Coordinate the availability of local training curricula, if applicable, for China R&D/SAF in collaboration with local and global training partners such as regional Q&C, LOC e-University· Support development of training materials for China R&D/SAF functional departments in collaboration with content owners.Quality monitoring & compliance· Support development of the Annual Quality Plan with remediation activities addressing compliance issues and risk signals· Coordinate and/or perform QC checks and remediation actions specified in Annual Quality Plan. Monitor progress and effectiveness of remediation actions· Support local and central business partners to facilitate (local) inspections and office audits as needed· Support local and central business partners in timely CAPA setting and implementation· On an ad hoc basis, perform activities such as On-Site Quality Monitoring and file checksData Quality, Metrics & Reporting· Support disclosure of clinical data on local public web, if applicable (CT.gov excluded)· Support to take oversight for system related data quality, e.g., TMS, CTMSRegulatory ComplianceLocal regulatory intelligence· Support RA Quality representative to perform impact assessments of new/revised local regulations, guidance and standards· Coordinate or support special investigation and issue remediation activities Clinical Registry· Make sure pre-registration for trials that received CTA in timely manner· Make sure fully-registration for trials under CFDA requirements· Routine maintain and update trial information in CDE-CFDA platform· Routine maintain and update registration tracker on the shared environment (SharePoint)· Share updated information from CDE to stakeholders· Key contact person with CDE Business DevelopmentVendor management· Support local vendor assessments, if applicable· Support activities related to annual DD update, certification and training of local vendors, if applicableBusiness QualityManagement Review· Support monitoring of compliance metrics, audit findings and issues (including appropriate escalation)· Support LOC Management Review in collaboration with LOC quality partners· Coordinate and/or participate in quality committee, if applicableQualifications:Education? A minimum of a Bachelor Degree in Science (BSc) or Arts (BA) or equivalent is required.? A minimum of 3 years of previous Pharmaceutical Industry experience is required, with at least 2 years of GxP experience within clinical research and development and/or quality assurance.Related Experience? Knowledge of the overall drug development process? Knowledge of business processes and practices (i.e., SOPs governing clinical research activities)? Experience in quality assurance activities, including audits of clinical investigative sites, systems and vendors, and audits of regulatory submissions is an asset? Good written and verbal communications skills in both Chinese and English? Conflict resolution/management and negotiation skills? Ability to independently plan, organize, coordinate, manage and execute assigned tasks? Experience of the key customers’ business processes and practices? Good working knowledge of FDA/ICH and country-specific regulations and guidelines related to clinical development;? Experience with regulatory submissions (NDA, BLA) is an asset; 职能类别：医药技术研发人员临床数据分析员关键字： SOP QC CRA 临床临床试验 regulation compliance

公司信息

公司简介(中文) 恢复为 “成立于1985年的西安杨森制药有限公司（“西安杨森”）是中国最大的合资制药企业之一，也是中国改革开放以来进入中国的最早一批制药公司之一，其总部位于北京的中央商业区。西安杨森是强生公司的一员。从创立之初，西安杨森就致力于引进和生产许多创新产品和高质量产品。西安杨森一直致力于投资未来，计划增加在生物制品、心脏病学、风湿病学和泌尿科学领域的新系列产品。西安杨森致力于利用这些新药改善中国患者的医疗保健状况。本着公司信条和关爱精神，西安杨森一直是活跃的企业公民，在医药、公共卫生、药物研发领域和企业社会责任方面从事了五十多项合作项目。例如，西安杨森与中国卫生部国际卫生交流与合作中心合作创立了“吴阶平医学研究奖和保罗•杨森药学研究奖”，旨在鼓励医药学领域的工作者不断创新。在过去的17年中，共计305名杰出医药学工作者在45个专业领域获得了该奖项，他们在科研领域做出了大量有价值的创新。此外，西安杨森也被誉为培养制药行业人才的摇篮。1999年，西安杨森被财富杂志（中文版）评选为“中国最受敬仰的十大外资企业之一”。2005年，西安杨森被中国中央电视台评选为“***雇主”，并且分别在2008年、2009年和2010年获得了“中国大学生***雇主奖”。目前西安杨森所有的招聘信息仅通过前程无忧，智联招聘和猎聘网进行发布，任何在非上述三家招聘网站看到的信息均非西安杨森正式发布。为避免对您的合法权益造成伤害，请务必通过正规渠道投递简历。 2013年，强生在西安高新区投资兴建强生全球供应链先进的生产基地，该项目建设目前已正式启动。新生产基地占地267,000平方米，将取代西安杨森在西安新城区现有的生产基地，成为强生供应链在亚洲的创新枢纽，从而更好地满足中国和其他新兴市场不断增长的需求。新的生产基地将采用世界***的制造技术和先进的质量体系，并引进集电子批号记录和数据存储于一身的全自动化配方生产操作系统以及先进的德国进口生产工艺设备。

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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