400-885-9898
职位已失效
更新于 5月5日

qa经理

1.5万-2.5万
  • 南通启东市
  • 5-10年
  • 本科
  • 招1人

职位亮点

五险一金全勤奖包吃定期体检免费班车员工旅游高温补贴节日福利

职位描述

任职资格

1、化学或药学本科及以上学历,有过6年以上药品质量管理的工作经验,有良好的GMP和法规指南的知识,具备良好的学习能力、团队合作、沟通协调能力,有较强的团队管理能力。良好的沟能和表达能力,良好的中英文读写能力。

2、对于中国GMP和ICH有充分的理解和认知,具备较强的专业知识,对于其他法规和指南有一定的理解和运用,能够熟练的运用各种工具来开展工作。

3、负责过公司级别的官方GMP现场检查,特别是2016年之后的CFDA,WHO,FDA,EDQM等官方检查者优先。

  

岗位要求

1、熟悉质量系统,生产设备系统和物料系统,以法规和指南为基准,熟练的起草修订和完善GMP文件系统,熟知各类验证确认的法规要求,并且与实际情况相结合。对于QA系统的处理流程如变更,偏差,OOS,投诉,CAPA,召回,自检,产品年度回顾,供应商管理,风险评估等熟知,并且有丰富的处理经验。

2、团队管理:制定并实施质量体系培训计划,为员工准备体系培训材料,提供质量体系培训,并建立人员资格认定文件。指导和帮助部门人员的业务工作,提高各岗位的工作效率。不断激励部门人员学习和提高自己,以提高团队的整体素质。组织活动提高员工质量意识,例如质量小组,质量知识竞赛等。负责本部门人员的绩效,做好部门内部的人才培养和储备工作。

工作地点

江苏省南通启东市滨江医药化工园区上海路338号
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公司Logo江苏诚信药业有限公司special-icon公司标签
www.cxpharma.com
江苏诚信药业有限公司是一家股份制高新技术企业,坐落于人杰地灵的、素有江海明珠之称的江苏启东市滨江医药化工园区,与上海崇明岛仅一江之隔,距上海市仅一小时车程,交通十分便捷。公司成立于2010年,占地面积60000平方米,固定资产总投入人民币3亿元,主要从事化学原料药及医药中间体的研发、生产和销售。公司非常注重科技创新和研发投入,并始终秉持“品质+创新”的核心理念,以“关爱人类健康”为宗旨,重点构建做细、做精、做强原料药系列化、规模化的特色产品,进一步推进和深化国际化发展战略,全面融入国际制药产业链,努力打造国内国际具有竞争力的制药企业。公司自创办以来,始终实施以“人才为本,科技为先,发展为重,共享共赢”的可持续发展战略,并一直以“追求卓越,福及众生”为使命,全力打造一流的诚信品牌,打造受人尊敬的企业。并始终坚持“人是一切之根本”的人才观念,坚持“用人唯才,任人为贤,人尽其才,才尽其用”的用人理念,坚持以“诚实笃信,唯实创新,同心同德,精益求精”企业精神,推动公司健康、快乐发展!公司秉承“以需求为导向,以双赢为目的,以质量为核心,以服务为手段”的经营理念,同时以品质引领市场,以创新获得差异,以成本赢得优势来满足客户的需求,并以诚信人热情和认真务实的工作态度,为广大客户提供最满意的产品和优质服务,我们将成为广大客户永远值得信赖的合作伙伴!Jiangsu Chengxin pharmaceutical co., LTD. Is a joint-stock high-tech enterprises, located in the beautiful, and known as jiangsu qidong jianghai pearl riverside pharmaceutical chemical industrial park, with the Shanghai chongming island, the only an hour's drive from Shanghai, the traffic is very convenient.The company was founded in 2010, covers an area of 60000 square meters, total investment in fixed assets 300 million yuan, mainly engaged in chemical active pharmaceutical ingredients and pharmaceutical intermediates research and development, production and sales. Company is very pay attention to scientific and technological innovation and r&d, and always uphold the"quality+ innovation" the core idea, in order to"care for human health" for the purpose, focus on building do fine, fine, and stronger API series, large-scale features of the product, to further promote and deepen the internationalization development strategy, fully into the international pharmaceutical industry chain, to build international competitive pharmaceutical enterprise in China.Company since its inception, always implement the"talent, technology first, development, sharing a win-win" the sustainable development strategy, and has always been to"the pursuit of excellence, and a blessing to all" for the mission, to create first-class brand integrity, create a respected enterprise. And always adhere to the"people is the foundation of all things" concept of talent, adhere to the"open to choose and employ persons, appoint none but people on their merit, to use" the concept of choose and employ persons, insist on"honesty belief, reality innovation, unite as one, excellence" spirit of enterprise, promote company development of healthy and happy!Companies adhering to the"demand oriented, in a win-win situation for the purpose, take the quality as the core, by means of service" business philosophy, leads the market by the quality at the same time, to get different innovation, win advantage with cost to meet customer demand, and people with sincere enthusiasm and earnest practical work attitude, for the overwhelming majority of customers with the most satisfactory products and quality service, we will become our customers forever trustworthy partner!欢迎访问公司主页了解更多关于江苏诚信药业有限公司的相关情况 www.cxpharma.com
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