质量经理
柯乾(上海)医药技术有限公司
- 公司规模:50-150人
- 公司性质:民营公司
- 公司行业:制药/生物工程
职位信息
- 发布日期:2019-03-17
- 工作地点:上海-浦东新区
- 招聘人数:若干人
- 工作经验:5-7年经验
- 学历要求:本科
- 职位月薪:25-30万/年
- 职位类别:医药技术研发管理人员
职位描述
全面负责公司的GMP/GSP质量体系, 营运质量管理, 质量审计等质量管理工作,主要工作职责为:
- 负责公司质量部门的建设,确保质量人力资源的建立和发展。
- 建立和维护公司的质量体系,确保符合国家GMP/GSP等相关质量规范。
- 建立和实施公司营运相关的质量保证体系和流程,在行业内保持领先地位。
- 代表公司,负责和协调客户,第三方或相关监管部门对公司的质量审计。
- 管理和推动质量偏差,客户投诉等质量问题的调查和整改,持续提高质量管理水平。
- 维护公司的文件控制体系,满足质量体系的要求。
- 负责和质量体系相关的供应商审计。
- 和营运部一起制定和实施质量体系或客户要求的设施设备的验证。
- 跟踪了解国家相关法规,在法规层面给公司和客户提供积极的咨询和建议。
- 主导对公司员工的质量和法规培训,推动质量第一的公司文化建设。
岗位要求:
- 本科或以上毕业于医药,物流,工程,生产或其他相关专业,为注册药剂师。
- 5年以上医药相关的质量管理经验,熟悉GMP/GSP等质量管理规范,了解国际上医药生产配送相关的质量管理规范
- 拥有良好的协调能力,团队合作能力和抗压能力,以结果为导向。
- 良好的英文书面和口语能力
- 熟练使用Office等办公软件,熟悉ERP系统的使用
职能类别: 医药技术研发管理人员
公司介绍
关于柯乾
What is ClinsChain?
柯乾医药是国内领先,按照国际标准和行业领先规范设立,由业内资深人士管理和运作的专业临床供应服务公司,秉承“以质量为中心的运作,以客户为中心的服务” 的企业文化,致力于为药品上市许可人和医药研发企业在国内外开展的临床试验提供卓越解决方案和一站式临床供应服务。
ClinsChain is a China-based company specializing in providing clinical supply services, which is running in the international and industry leading standards, and managed by industry veterans. With the principal “Quality-oriented Operation, Customer-oriented Service”, ClinsChain is devoted to provide the professional and high-quality one-stop clinical supply services and solutions to MAHs and pharmaceutical R&D enterprises for local or global clinical trials conduction.
柯乾医药的营运体系兼顾GMP/GSP要求和临床试验项目的特殊性,通过卓越的项目管理和营运执行能力,对临床前、一期二期三期以至上市后临床的全方位临床供应提供全面的支持。
ClinsChain operation system takes into consideration requirements of both GMP/GSP and clinical trials. It provides full coverage support to your clinical operation across different phases of clinical trials through leading project management and operation execution capabilities.
柯乾医药严格按照国际通用和我国相关GXP设立自身的质量管理体系,保障临床供应运作的质量符合国内外的合规要求,并于2018年6月通过SGS基于WHO GMP/GDP的质量体系认证,于2019年7月通过欧盟QP审计。
The ClinsChain quality system, which is set up by strictly following the requirements of GMP and related GxP, secures operation quality and regulatory compliances. ClinsChain received GMP/GDP certificates issued by SGS in June 2018 and was certified by EU QP in July 2019.
柯乾医药自成立以来已经为国内外近百家医药和生物药企提供药品/物资采购,仓储,物流,包装,进出口等全方位的专业临床供应服务,以质量合规、服务高效,贴近中国市场和客户需求,以及优异的性价比得到了业内客户的高度认可。
ClinsChain has established its reputation in the industry by being excel in professionalism, quality, efficiency and client oriented services. ClinsChain has provided various clinical supply services including comparator/ancillary sourcing, storage, distribution, packaging, import/export, etc. to dozens of local and global clients.
伴随着国内医药行业的迅速发展,柯乾医药的业务在国内外呈现全面快速的增长,公司已在北京设立可支持各种业务运作的分公司,并正在全面提升国际的覆盖和运作能力,为客户提供更好更全面的服务。在此,诚邀各路有识之士加入柯乾医药的大家庭。
With the rapid development of the domestic pharmaceutical industry, ClinsChain's business is growing rapidly both at home and abroad. The company has set up branch in Beijing to support various business operations, and is improving its international coverage and operation ability to sustain our first class service to our customers. You, the ideal talent we are looking for, are welcome to join the ClinsChain family and grow up together.
柯乾可以给您什么?
What can ClinsChain offer?
- 具有几十年专业和外资背景的管理团队
Management team with decades of professional and foreign company background
- 优良的工作环境和积极向上的团队合作氛围
Excellent working environment and positive teamwork atmosphere
- 有竞争力的薪资待遇和完全规范的社保保障
Competitive salary & benefit and fully compliance with social security allowance
- 体系化的培训保证员工的融入和提升
Systematic training for integration and development
- 快速成长的公司业务和无限个人发展的空间
Blooming business and unlimited career development opportunities
What is ClinsChain?
柯乾医药是国内领先,按照国际标准和行业领先规范设立,由业内资深人士管理和运作的专业临床供应服务公司,秉承“以质量为中心的运作,以客户为中心的服务” 的企业文化,致力于为药品上市许可人和医药研发企业在国内外开展的临床试验提供卓越解决方案和一站式临床供应服务。
ClinsChain is a China-based company specializing in providing clinical supply services, which is running in the international and industry leading standards, and managed by industry veterans. With the principal “Quality-oriented Operation, Customer-oriented Service”, ClinsChain is devoted to provide the professional and high-quality one-stop clinical supply services and solutions to MAHs and pharmaceutical R&D enterprises for local or global clinical trials conduction.
柯乾医药的营运体系兼顾GMP/GSP要求和临床试验项目的特殊性,通过卓越的项目管理和营运执行能力,对临床前、一期二期三期以至上市后临床的全方位临床供应提供全面的支持。
ClinsChain operation system takes into consideration requirements of both GMP/GSP and clinical trials. It provides full coverage support to your clinical operation across different phases of clinical trials through leading project management and operation execution capabilities.
柯乾医药严格按照国际通用和我国相关GXP设立自身的质量管理体系,保障临床供应运作的质量符合国内外的合规要求,并于2018年6月通过SGS基于WHO GMP/GDP的质量体系认证,于2019年7月通过欧盟QP审计。
The ClinsChain quality system, which is set up by strictly following the requirements of GMP and related GxP, secures operation quality and regulatory compliances. ClinsChain received GMP/GDP certificates issued by SGS in June 2018 and was certified by EU QP in July 2019.
柯乾医药自成立以来已经为国内外近百家医药和生物药企提供药品/物资采购,仓储,物流,包装,进出口等全方位的专业临床供应服务,以质量合规、服务高效,贴近中国市场和客户需求,以及优异的性价比得到了业内客户的高度认可。
ClinsChain has established its reputation in the industry by being excel in professionalism, quality, efficiency and client oriented services. ClinsChain has provided various clinical supply services including comparator/ancillary sourcing, storage, distribution, packaging, import/export, etc. to dozens of local and global clients.
伴随着国内医药行业的迅速发展,柯乾医药的业务在国内外呈现全面快速的增长,公司已在北京设立可支持各种业务运作的分公司,并正在全面提升国际的覆盖和运作能力,为客户提供更好更全面的服务。在此,诚邀各路有识之士加入柯乾医药的大家庭。
With the rapid development of the domestic pharmaceutical industry, ClinsChain's business is growing rapidly both at home and abroad. The company has set up branch in Beijing to support various business operations, and is improving its international coverage and operation ability to sustain our first class service to our customers. You, the ideal talent we are looking for, are welcome to join the ClinsChain family and grow up together.
柯乾可以给您什么?
What can ClinsChain offer?
- 具有几十年专业和外资背景的管理团队
Management team with decades of professional and foreign company background
- 优良的工作环境和积极向上的团队合作氛围
Excellent working environment and positive teamwork atmosphere
- 有竞争力的薪资待遇和完全规范的社保保障
Competitive salary & benefit and fully compliance with social security allowance
- 体系化的培训保证员工的融入和提升
Systematic training for integration and development
- 快速成长的公司业务和无限个人发展的空间
Blooming business and unlimited career development opportunities
联系方式
- 公司地址:上海市浦东新区上丰路700号8幢101室