Quality Control Manager
上海勃林格殷格翰药业有限公司
- 公司规模:1000-5000人
- 公司性质:外资(欧美)
- 公司行业:制药/生物工程
职位信息
- 发布日期:2014-05-30
- 工作地点:泰州
- 招聘人数:1
- 工作经验:十年以上
- 学历要求:大专
- 语言要求:英语精通
- 职位月薪:30000-49999
- 职位类别:生物工程/生物制药
职位描述
Basic Purpose of the Position
Manages the Quality Control unit’s core operations to assure scientific robustness, accuracy and compliance of all tests/procedures for compliance with corporate, OSHA, EPA, FDA, USDA, EMEA, Japanese, cGMPs and regulatory requirements from other countries where BIVI product is marketed.
Accountabilities
?Responsible for the testing and release of raw materials, in-process samples containers/closures, packaging materials, toll/contract manufactured products and BIVI manufactured products.
?Determines technical adequacy of the scientific documents and testing methods used within Quality Control. Reviews calculations and testing performed within Quality control.
?Responsible for bringing new technology and procedures into QC for optimizing compliance and efficiency. Responsible for Method validation,method transfer validation and transfer of methods to contract testing laboratories.
?Prepares and allocates the department budget for Quality Control.
?Ensures the proper administration of the BIVI stability program including evaluation of trends/testing at appropriate intervals as per Regulatory commitments.
?Responsible for expeditious testing for resolution of product quality complaints and adverse events complaints.
?Responsible for improvement of current QC tests and developing new QC tests with R&D to instigate new QC tests needed for new products.
?Responsible for the implementation of and adherence to safety guidelines in the QC laboratory.
?Responsible for timely and efficient QC testing to meet required schedules.
?Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management.
?Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community.
Requirements
?Masters degree in relevant scientific area (analytical chemistry or other chemistry area, biochemistry, virology or bacteriology)
?High proficiency in statistical analysis, use of specialized computer data bases such as LIMs, Stability, and other relevant computer software programs associated with area of responsibility.
?Proficiency compliance regulations such as GMPs, GLPs , ICH, SFDA and MOA.
?Minimum of 3 years experience of managing laboratory functions in a cGMP/USDA regulated facility.
?Good Command in English.
Manages the Quality Control unit’s core operations to assure scientific robustness, accuracy and compliance of all tests/procedures for compliance with corporate, OSHA, EPA, FDA, USDA, EMEA, Japanese, cGMPs and regulatory requirements from other countries where BIVI product is marketed.
Accountabilities
?Responsible for the testing and release of raw materials, in-process samples containers/closures, packaging materials, toll/contract manufactured products and BIVI manufactured products.
?Determines technical adequacy of the scientific documents and testing methods used within Quality Control. Reviews calculations and testing performed within Quality control.
?Responsible for bringing new technology and procedures into QC for optimizing compliance and efficiency. Responsible for Method validation,method transfer validation and transfer of methods to contract testing laboratories.
?Prepares and allocates the department budget for Quality Control.
?Ensures the proper administration of the BIVI stability program including evaluation of trends/testing at appropriate intervals as per Regulatory commitments.
?Responsible for expeditious testing for resolution of product quality complaints and adverse events complaints.
?Responsible for improvement of current QC tests and developing new QC tests with R&D to instigate new QC tests needed for new products.
?Responsible for the implementation of and adherence to safety guidelines in the QC laboratory.
?Responsible for timely and efficient QC testing to meet required schedules.
?Performs all Company business in accordance with all regulations (e.g., EEO, FDA, etc.) and Company policy and procedures. When violations are noted/observed they are to be immediately reported to management.
?Demonstrated high ethical and professional standards with all business contacts in order to maintain BIVI’s excellent reputation in the community.
Requirements
?Masters degree in relevant scientific area (analytical chemistry or other chemistry area, biochemistry, virology or bacteriology)
?High proficiency in statistical analysis, use of specialized computer data bases such as LIMs, Stability, and other relevant computer software programs associated with area of responsibility.
?Proficiency compliance regulations such as GMPs, GLPs , ICH, SFDA and MOA.
?Minimum of 3 years experience of managing laboratory functions in a cGMP/USDA regulated facility.
?Good Command in English.
公司介绍
关于勃林格殷格翰
加入勃林格殷格翰,与我们一起携手并肩,共创未来。我们深信每一位员工的成长都将铸就公司的发展,每一位员工的努力也都将成就公司的美好明天。130余年来,研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一,持续致力于人用药品、动物保健和生物制药合同生产三大业务领域,力争为人类和动物带来更多健康。加入勃林格殷格翰,将是您实现“创新展现价值”的绝佳机会!在工作中,您将通过与内外部伙伴的通力合作,站在知识迭代的最前沿;科研过程中,您将不断探索新型科学发现,切实提高全人类的生活质量;与此同时,您也将助力公司成为未来行业当之无愧的领导者。
我们的业务正处在持续高速发展之中,是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰,共同携手向前,成为实现2025愿景的一份子。
作为业内的领导企业,热情、创新和独立是驱动我们不懈前行的动力,我们为每一位努力热忱、恪尽职守的员工提供成长机会,实现其个人价值。作为连续七年通过“中国杰出雇主”认证的企业,我们通过提供高质量的职业发展规划、参与或领导国际项目的机会,为每一位员工的成功之路夯实基础。
让我们彼此成就,引领未来!
想获取更多信息,有以下方式:
1. 访问************************************/或
2. 关注我们领英账号, 或
3. 关注我们的微信公众号:BI招聘
行为准则
-责任心:即使情况不明朗,我们总是在自己的决策和行为中展现主人翁精神
-敏锐度:面对内外部变化时,我们以开放的心态快速应对
-内部企业家精神:我们与客户携手构筑创新理念,以应对瞬息万变的市场
联系我们
如果你坚信自己就是我们要找的人,不要犹豫,马上申请吧!
加入勃林格殷格翰,与我们一起携手并肩,共创未来。我们深信每一位员工的成长都将铸就公司的发展,每一位员工的努力也都将成就公司的美好明天。130余年来,研发驱动型制药公司勃林格殷格翰作为全球前20大制药企业之一,持续致力于人用药品、动物保健和生物制药合同生产三大业务领域,力争为人类和动物带来更多健康。加入勃林格殷格翰,将是您实现“创新展现价值”的绝佳机会!在工作中,您将通过与内外部伙伴的通力合作,站在知识迭代的最前沿;科研过程中,您将不断探索新型科学发现,切实提高全人类的生活质量;与此同时,您也将助力公司成为未来行业当之无愧的领导者。
我们的业务正处在持续高速发展之中,是中国业内发展最快的公司之一。我们诚邀您加入勃林格殷格翰,共同携手向前,成为实现2025愿景的一份子。
作为业内的领导企业,热情、创新和独立是驱动我们不懈前行的动力,我们为每一位努力热忱、恪尽职守的员工提供成长机会,实现其个人价值。作为连续七年通过“中国杰出雇主”认证的企业,我们通过提供高质量的职业发展规划、参与或领导国际项目的机会,为每一位员工的成功之路夯实基础。
让我们彼此成就,引领未来!
想获取更多信息,有以下方式:
1. 访问************************************/或
2. 关注我们领英账号, 或
3. 关注我们的微信公众号:BI招聘
行为准则
-责任心:即使情况不明朗,我们总是在自己的决策和行为中展现主人翁精神
-敏锐度:面对内外部变化时,我们以开放的心态快速应对
-内部企业家精神:我们与客户携手构筑创新理念,以应对瞬息万变的市场
联系我们
如果你坚信自己就是我们要找的人,不要犹豫,马上申请吧!
联系方式
- Email:HRTACampusWest.CN@boehringer-ingelheim.com
- 公司地址:地址:span张江李时珍路257号