[北京]拜耳医药保健有限公司

职能类别:药品生产/质量管理

As QA supervisor to lead team member to ensure the quality assurance activities to be in line with national and international GMP standards. Strictly obey the existing compliance, Bayer quality standards, and as the authorized release person to ensure only the qualified products to be released.

1. As QA supervisor to lead the team member to handle all quality issues, clarify the problem and investigate the root cause together with the supervisors/managers of production, Engineer and warehouse, then make the decision for immediate actions as soon as possible, not only ensure the product quality, but also need to consider the production efficiency; then find the corrective and preventive actions and discuss them with the supervisor of the related departments, push the staff to follow the actions and monitor to ensure the production smooth running in compliance with GMP requirement.

2. As QA supervisor to organize the team member to review batch record and inspect the sample in time, monitor the release status of every batch, investigate the issues to release the product on time to ensure plant smooth running, inventory safety and market supply.

3. As the authorized release person to make decision to release/reject every batch the locally manufactured and packaged products, not only check all important information on the batch documents, the quality of the samples and test results, but also confirm the investigation for the issue is clear or not, the actions for the issues is enough or not, to ensure all released products comply with Bayer global & local registered specifications and local GMP regulation, no risk to the patients, no recall.

4. As the authorized release person to make decision to release/reject packaging materials according to the purchasing and testing specification and 100% ensure only qualified material can be released to ensure the product quality.

5. As the plant leader of handling deviation to lead all related departments of the whole plant to investigate the root cause of deviation, check the investigation and actions is enough or not, evaluate the corrective and preventive, then report every deviation to plant management team, get the approval from the quality head and the site manager. And monitor deviation trend of the plant, report it to management team every month, if abnormal, discuss the actions with the related department head, follow up and monitor the performance of the actions, to prevent the deviation reoccurrence and ensure the products quality and no risk in GMP compliance. Meantime, handle the whole deviation investigation and management process in Dev@Com system as a key gatekeeper.

6. Organize and prepare for Bayer internal inspection and authorities on-site GMP inspection; submit registration to authorities (e.g. facilities and equipment change or new production line, etc.), and ensure all inspections can be passed successfully.

7. As the quality representative to review the GMP related documents, such as SOPs, manufacturing master batch record, calibration and maintenance documents, monitoring report of environment, HVAC, Purified water system, e.g., to ensure the compliance and effective running of the quality management system. Perform the annual product quality review, review and check the quality level of related products; if the weakness is found, need to investigate the root cause and align the actions with production supervisor, follow up and push the actions to improve the quality of this product.

8. Create/revise GMP related SOPs according to new requirements and directives, including design and check the operation procedures to ensure the procedures is reasonable and compliable, make the operation procedures to follow easily, and monitor the procedures to be followed strictly to ensure the product quality and GMP compliance.

Ensure the released products comply with the regulatory requirements and Bayer global standards and have no negative impact on the company business in China.

1. Education: Bachelor degree of Pharmaceutical science or related.

2. Experience:

? Total more than 8 years’ experience in the pharmaceutical company.

? More than 6 year experience in the field of QA.

? More than 1 year experience in release product and handling deviation

3. Knowledge & Skills:

? Familiar with product release

? Familiar with production process and equipment, operation procedure

? Familiar with quality system management

1. Education: Bachelor degree of Pharmaceutical science or related.

2. Experience:

? Total more than 8 years’ experience in the pharmaceutical company.

? More than 6 year experience in the field of QA.

? More than 1 year experience in release product and handling deviation

3. Knowledge & Skills:

? Familiar with product release

? Familiar with production process and equipment, operation procedure

? Familiar with quality system management

公司名称:拜耳医药保健有限公司 公司类型:合资 公司规模:500-1000人 公司介绍: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。