China Pharma R&D Quality & Compliance Specialist
职位描述
职位描述:
Quality Processes
Process, 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 and BRQC process and development
Training 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 checks
Data 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, CTMS
Regulatory Compliance
Local 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
Business Development
Vendor management
? Support local vendor assessments, if applicable
? Support activities related to annual DD update, certification and training of local vendors, if applicable
Business Quality
Management 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 applicable
Others
? If applicable, support country specific quality management activities including but not limited to organizing cross-departmental quality meetings
企业简介
美国强生公司创建于1886年,目前在全球60个国家建立了250多家分公司,是目前世界上最具综合性、业务分布范围最广的卫生保健产品的制造商和相关服务提供商,业务领域主要包括制药,医疗器械和消费品。
西安杨森制药有限公司是美国强生公司在华最大的子公司,成立于1985年。公司管理中心在北京,生产基地位于西安,在全国28个城市设有办事处,在华员工超过3000人。在过去的25年中,西安杨森保持持续稳定发展,成为了中国领先的合资制药企业。
西安杨森不断引进和生产多种创新的、高品质的药品,其产品包括多种高质量的处方药,以及广受患者信赖的非处方药物。西安杨森依托强生公司全球强大的研究开发体系,着眼于未来,不断引进新的药品,计划上市生物制剂、肿瘤、心血管、风湿和泌尿等更多领域的产品以服务于中国的广大患者。
西安杨森公司遵从强生信条的原则,致力于公司的长期发展。这是公司在过去取得成功的基石,也是未来成长的保障。
西安杨森公司获得众多奖项和赞誉,比如《财富》杂志评选的“中国最受赞赏的外资企业”及“人力资源经理眼中的热门雇主”;中国中央电视台 “2005CCTV中国年度雇主”;CRF评选的2007-2008年度北京地区“中国杰出雇主”;2008年与强生在华公司一起荣获“第六届中国大学生最佳雇主奖和进步飞速奖”称号,和2009年“第七届中国大学生最佳雇主奖”,并位列医药行业第一名。2010年强生在华公司荣获“第八届中国大学生最佳雇主制药/医疗行业最佳雇主第一名”。这是继上届强生公司获得医药行业第一名后再次蝉联这项荣誉。
北京相关职位: 医药信息代表(儿童肥胖DSM)
热门区域招聘: 重庆 北京 上海 浙江 江苏 广东 山东 湖南 安徽 河北
北京招聘企业: 叮当智慧药房(北京)有限公司 北京久峰润达生物技术有限公司 北京协和医院 北京海斯美医药技术有限公司 北京策知易咨询有限公司 北京万泰生物药业有限公司 百济神州 北京凯霖娜国际贸易有限公司好益生医院分公司 中国生物制药有限公司 国药集团工业有限公司
职位发布日期: 2016-11-23