Sr QC Specialist 北京

月薪：

该公司所有职位
  • 8-9年经验
  • 本科
  • 招若干人
  • 11-09 发布

职位描述

职位描述： Major tasks and responsibilities of position:Raw material:1. Independently test of package material, API, raw material, purified water, etc., according to approved test procedure and specification;2. Mainly responsible for the test results review, to assure all the test data quality and integrity, Data review must also include a review of relevant metadata, including audit trail;4. Create analytical method of raw material and perform method validation, as well as perform method verification for pharmacopeia method.5. Provide technical support to other department including Regulatory department and Government affairs department.6. Responsible for the QC instrument/system calibration management according to BHC SOPs.7. Revise SOPs and test procedures according to according to BAG directives/regulations/SOPs and Pharmacopoeia or registration specification.8. Training new staff and share the rich experience to team.Microbial:1. Establish Microbial limit test method and perform method validation, as well as prepare validation protocol and report.2. As PSS project leader of QC lab, create QC KPI and control measurement for whole lab. Organize daily dialogue and establish standard work. As well as support PSS site leader to implement this project in each 3 QC labs.3. Manage equipment of the microbial lab ensuring that the equipment are functional (calibrated and well maintained) and suitable for testing. Create instrument qualification protocol and report, as well perform qualification.4. Independently perform test of raw materials, bulk, finished goods, routine monitoring environment and others (including purified water, potable water, compressed air, drain and sink etc.). Ensure that testing is carried out in compliance with specifications.5. Summary the annual monitoring results, analyse the trend and evaluate the trend whether impact to product.6. Initial OoS investigation, and organize and coordinate other departments including production and engineering involve in OoS investigation. Support microbial leader to establish investigation plan and perform investigation to ensure OoS investigation is conducted properly.7. Check monitoring data to ensure all data is correct and reliable.8. Training new staff and share the rich experience. According to skill matrix give all microbial lab improvement training.化学检测-制剂检测:1. Independently test of bulk, stability research, validation (including production validation and cleaning validation) and cleaning monitor according to approved test procedure and specification.2. Mainly responsible for the test results review, to assure all the test data quality and integrity, Data review must also include a review of relevant metadata, including audit trail.3. To keep KPIs to meet with production plan and controlling department.4. Create analytical method and develop test method for cleaning validation and dissolution test.5. Provide technical support to other department including Regulatory department and Government affairs department.6. Responsible for the QC instrument/system calibration management according to BHC SOPs.7. Revise SOPs and test procedures according to according to BAG directives/regulations/SOPs and Pharmacopoeia or registration specification.8. Responsible for core documents store and destruction in QC formulation lab. Follow up with the global core documents in local QC lab.Qualifications:1. Education: Bachelor degree of Pharmaceutical science or related.2. Experience:More than 8 years’ experience in the pharmaceutical company.3. Knowledge & Skills:Familiar with Chinese GMP and EU GMP;Good operational skills on lab instruments (HPLC, GC, IR, UC etc.);Good communication, presentation and interpersonal skills; Familiar with MS Software including Word，Excel，PowerPoint;Fluent in English speaking and writing. 职能类别： 药品生产/质量管理 质量管理/测试主管(QA/QC主管)

联系方式

经济技术开发区荣京东街7号

公司信息

拜耳医药保健是拜耳集团的子集团，是世界十大医药企业之一，也是医药保健及医疗产品行业世界领先的创新企业之一，全球拥有员工53100人，总部位于德国的勒沃库森。拜耳医药保健致力于研究开发、生产和销售用于预防、诊断和治疗疾病的原研产品。2008年，拜耳医药保健全球销售额达154.07亿欧元，其中研发经费为17.42亿欧元，占拜耳集团总研发投入的66%。 拜耳医药保健和中国的渊源可以追溯到20世纪初期。早在1936年，拜耳就在中国成立第一个生产公司－拜耳医药公司，生产一系列产品。目前，拜耳医药保健有限公司在中国拥有员工约4000人，总部位于北京。在北京、广州、成都、江苏设有工厂，致力于拜耳先灵医药、保健消费品、糖尿病保健及动物保健四大业务。其中，拜耳先灵医药是拜耳医药保健有限公司下属最大业务部门，是拜耳医药保健的处方药部和先灵（广州）药业有限公司合并而成，业务遍及70多个城市，产品线覆盖普药业务、女性健康、特殊治疗以及影像诊断四个领域。2008年7月，拜耳医药保健的保健消费品部收购了东盛盖天力西药非处方药业务。 2008年，拜耳医药保健完成了投资达2.2亿余元人民币的北京生产厂的扩建。 北京工厂新建的生产线将采用目前中国乃至亚洲地区最为先进的设备，产能是以前的4倍。除了硬件系统投资，拜耳医药保健北京工厂还引入先进的软件管理系统，包括全自动称重系统、物流管理系统等将使得药品的品质更上一层楼。 拜耳医药保健有限公司在中国的发展蒸蒸日上。 在业务发展的同时，拜耳医药保健始终不忘社会责任，积极与社会各方面进行深入合作。2008年11月，与中国就业促进会合作开展了“农业富余劳动力健康安全转移就业培训项目”，计划在3年内对3万名农业富余劳动力免费提供健康安全转移就业培训。尽管目前处在全球经济困难期，我们仍将继续关注那些需要帮助的社会弱势人群。 为促进并提高中西部地区县级医院的整体医疗服务技术水平，2008年拜耳医药保健和卫生部合作的“走进西部”万名县级医院医师培训项目成功开展。目前已在甘肃、青海、宁夏、云南四省进行了６期培训工作，已有３６３人参加了培训。２００９年“走进西部”项目还将延伸到江西、广西、陕西、贵州、新疆等五个省份，共计划培训１１２２名医生。 2009年初，拜耳医药保健新的研发中心将在北京落户，成为其全球架构中的第四大研发中心。这一举措不仅表明了我们在中国长期发展的决心和信心，并为拜耳医药保健成为亚洲制药领域的领导者提供坚实基础。

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