Quality Manager, China 北京

月薪： 25-45万/年

该公司所有职位
  • 无工作经验
  • 招1人
  • 03-06 发布

职位描述

Title: Market Surveillance Quality Manager (China)Location: BeijingSummary: Improve the Post-Market Surveillance (PMS) process management as part of safety and efficacy monitoring, being the company representative through China Testing Centers, External authorities and internal cross-functional areas, ensuring a consistent level of information and response, as a single point of contact. Building relationship with Testing Centers to enhance inter-laboratory expertise in Test Methods execution and results interpretation, tracking and trending analysis, adherence between corporate control plans and China national standards, risk management (in case of deviations), and preventive approach application. Perform regular monitoring of key elements of MS Process compliance and efficacy, as MS trending (in market), competitors best practices and performance, complaints management, GMP (vs local requirements), emerging risks to support corrective, preventive and continuous improvement process. The individual should have knowledge of Quality Management System, Post-Market Surveillance process and legislation (China), GxP practices (GMP, GLP, and GDP), in-country representation, and risk management. Responsibilities:China/all products Implement the PMS internal process as per local and global RB standards, to lead all PMS casesEnsure that improvements to products and procedures can be identified and fixed, together with cross-functional team.Ensure that QMS is maintained in a state of inspection readiness for PMS process.Work with local functions to develop and maintain this process in line with the requirements of the Global BMS & associated policies, relevant codes of practice and local legislation.Be the contact point for external bodies performing PMS with RB (China) products for proper level of response, relationship building, trending and results trackingKeep records, following RB Global Quality Policy for Data Integrity management (attributable, legible, contemporaneous, original and accurate).Closer tracking of all PMS cases (tracking table) and keep internal cross-functional PMS team regularly informed by systematic reports of status.Link the PMS with the Critical Event Management Process in case of deviation or non-expected situation.Perform regular SWOT (strengths, weakness, opportunities, and threats) analysis to drive documented improvement or corrective initiatives. Conduct the weekly review of complaints and external market surveillance cases (including the competitors) to have CAPA plan in placeLead the QMS/GDP audit master plan and the monthly QMS/GDP reviewLead market surveillance related CAPA review, verification of the CAPA completion. PROFESSIONAL QUALIFICATIONS/ EXPERIENCE At least 5 years of experience working in R&D, Quality and or Regulatory Compliance function in a Healthcare, Hygiene, Pharmaceutical, or Medical Device related industry. Experience in developing and performing analytical, physical and chemical test methods Clear understanding and ability to assess and act upon product safety, quality, efficacy and compliance risks. Good understanding of typical regulatory requirements relevant to a regulated product e.g. EU GMP, WHO, PIC/S, CFR 21 Part 111/ 210/ 211/ 820, local legislation 职能类别： 药品生产/质量管理 关键字： QA Manager

联系方式

北京市朝阳区东大桥路9号侨福芳草地大厦D座6层

公司信息

利洁时是全球500强企业，是全球最大的家用清洁及个人护理消费品公司之一，总部位于英国伦敦。在60个国家运作高品质的家用清洁用品、个人护理用品和药品，产品行销180个国家和地区。我们的历史可以追溯到18世纪：在英国生产面粉的Reckitt和在德国生产工业化学原料的Benckiser。1888年开始，我们已经开始在伦敦股票交易所上市，通过合资，以及有选择性的并购，我们已经成为富时指数前25位的全球性公司。利洁时在中国的发展一直以生产和推广高品质的家庭清洁和个人卫生护理用品、推动中国健康护理事业的发展目标。作为蜚声国际的跨国企业，利洁时在中国市场生产和销售高质量的知名品牌家庭清洁产品。开发极具潜力的市场，始终是利洁时公司投资的核心战略之一。1995年利洁时来到中国，在广州成立了第一家合资企业-利高曼（广州）有限公司，1996年与湖北活力28集团合资组建了湖北活力美洁时洗涤用品有限公司，从此扎根荆州，开始了利洁时投资中国市场的历程。随着中国国际地位的提升，在加大投资及完成中国区域资源整合的同时，利洁时更坚定了在中国投资的信心。2006年，在中国成立了利洁时家化（中国）有限公司（利洁时全球全资子公司）。为了使中国区的工厂真正成为国际生产基地，几年来利洁时在中国的投资势头不减，在组织结构调整和人员配备方面更是格外重视。2010年随着利洁时全球收购了SSL集团，利洁时在中国增加了新的产品品牌，工厂以及团队。目前利洁时中国的品牌有：Dettol （滴露）Veet （薇婷）Finish （亮碟）Airwick (安悦嘉）Dosia （巧手）Durex （杜蕾斯）Scholl （爽健）Vanish（渍无踪）我们以我们自己在这个高度竞争的全球市场中创造的成绩而骄傲，并深刻意识到我们的成功是直接和我们善于接受挑战，充满热情和才华的员工联系在一起的。想要了解我们更多的历史和信息，请参阅公司网站 www.rb.com

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