天津招聘

Responsibility 职责

本岗位负责同生产合作确保过程遵照百特标准，按照计划对生产过程进行检查, 依据标准操作规程完成所有的与生产过程相关的质量控制，根据AQL进行成品取样检查。

Specific Responsibilities 具体工作职责

• Perform  on site inspection for inner bag/frangible/assembly and drug products manufacturing process based on GMP/ISO/SOPs.根据GMP/ISO/SOPs的要求对内袋、易碎管、附件及药品生产过程进行检查。          
• Coordinate to handle any exception in process timely in order to eliminate negative impact to finished goods quality. 及时协调处理异常情况，以消除对产品的影响。
• Draft QE SOPs, production SOP comment and finish related quality documents. 起草SOP，批注生产SOP，完成相关质量文件。
• Ensure processes are complied with SOPs and ensure in-process control and final functional test are inspected on time.  确保过程遵照SOP的要求，确保中间产品控制和功能检查及时进行。
• Collect and analyze statistic data for manufacturing process. 收集分析生产过程数据。
• Implement or support process or projects validation. 进行或支持生产过程和项目验证。
• Support in process/product improvement, to ensure each improvement to be validated. 支持过程和产品的改进，确保每一个改进均进行验证。
• Establish and maintain internal critical system, review and follow up any nonconformance or observation in internal and external quality audit.建立并维护内部关键系统，回顾并跟踪内部和外部质量审计中的不符合项目。
• Cascading Corporate Quality Manual/Policy and ensure appropriate SOPs and Forms.逐级执行集团质量手册/方针并确保其相关SOP和表格的执行。
• Initiate ICAR/SCAR due to supplier quality issues.发起由供应商原因引起的内部供应商投诉/供应商投诉
• Assist to investigate customer complaint. 协助调查客户投诉。
• Provide QE Support for drug production, such as procedure set up, in-process  testing instrument purchasing and validation, training, validation supporting to production team and engineering team. 提供药品生产QE方面相关支持，如程序建立，中控检测仪器的购买，验证，对于生产团队及工程团队的培训、验证支持等。
• Monitor and manage the warehouse based on GMP/ISO/SOPs.  根据GMP/ISO/SOPs的要求对仓库进行监督及管理。
• Be responsible for outside warehouse’s daily work management. Ensure everyday action to be complied with SOP standard of warehouse. 
• The main responsibilities include: 

1. Be responsible for checking for material status,
2. finish goods status、number etc. And ensure they are complied with system;
3.  Be responsible for checking the unload、binning and sampling operations complied with Baxter’s SOP; 
4. Be responsible for checking labeling, labeling approach, and the number of label correct or not;Be responsible for checking goods on right place and complied with all EHS request; 
5. Be responsible for checking relevant facilities; Check the humidity and temperature within spec; 
6. Be responsible for checking Goods Receipt Note; 
7. Be responsible for checking pest control and rodent control；
8. Be responsible for checking for the control and usage of final product labeling

           监督外仓的日常工作管理，确保外仓每天的操作符合百特SOP的要求。
         其中主要职责包括：检查现场物料状态、成品状态、数量等信息，确保与系统上一致；

1. 检查现场卸货、装箱、取样等操作是否按照SOP规定执行；监督标签粘贴、粘贴方法及数量是否正确；
2. 检查现场摆放，是否存放在正确的区域，是否按照EHS相关要求摆放等；
3. 检查相关设备; 检查温湿度是否符合要求; 负责检查物料和成品接收记录;
4. 检查防虫、驱鼠设施；标签发放记录是否及时、准确、真实等。

Requirements 职位要求

• At least a college degree or above in pharmaceutical, medical or chemical.药学，医学或化学相关专业专科及以上学历。
• At least 2 years of working experience in quality control and quality assurance. 2年以上质量管理的工作经验。
• Good judgment and independent on quality control process.良好的判断力和独立质量控制工作能力
• Be able to read and understand English documents.能够阅读理解英语文件。
• Good human relationship skills. 良好的沟通能力。
• Can adapt to shift work. 能适应轮流倒班。

特别注明：苏州百特的所有招聘岗位仅通过圆才网和前程无忧网进行发布和收集简历！苏州百特的联系地址只有一个，白榆路27号。

每一天，百特影响着数以百万计的生命，我们凭借必要的医院和肾科产品与服务应对重大健康需求。在全球，几乎每个医院的每个科室，乃至每一楼层，都能发现百特产品与疗法的身影。同时，百特也出现在诊所和患者家中。
Every day, Millions of lives relay on Baxter, Our products and service are essential building blocks of healthcare. Baxter products and treatment are found almost in everyplace, in every hospital at every Department even on every floor. Meanwhile, Baxter is there, not only the clinic but also our patient home.

百特于上世纪80年代来到中国，是***进入中国医疗市场的大型跨国医疗企业之一。秉承“拯救并延续生命”的企业使命，百特专注于协助提升医疗标准、扩大医疗可及性和回馈社会等关键性工作，为中国患者的生命和生活质量做出有意义的贡献，助力中国医疗事业的可持续发展。
In the 80s Baxter has come to China which is one of the earliest multinational medical enterprise, Our mission to save and sustain lives inspires our work and our commitment to expanding access to care, providing cost-effective healthcare solutions, delivering quality products and advancing innovations, also delivering contribution to our patient and their Quality lives meanwhile it will be supportive of sustainable development for Chinese medical treatment cause

苏州百特医疗用品有限公司成立于1995年, 是百特在中国建立的***家独资工厂，主要生产静脉输液袋、腹膜透析袋及相关组件，以用于静脉输注及腹膜透析治疗。我们始终严格执行中国质量管理体系，确保我们的产品以***质量和安全标准为患者及医护人员服务。目前, 560多名员工正运用最创新和先进的制造技术，为中国大陆、中国台湾、新加坡、澳大利亚、菲律宾及泰国等国家和地区的客户提供优质高效的医疗产品，为依赖于百特产品的患者带去有意义的改变。

Suzhou Baxter healthcare co., LTD is founded in 1995, This is the first sole plant in China. Baxter Suzhou produced venous transfusion container, PD bag and other related components which used in PD and venoclysis treatment, In order to provide the high-quality product, and let our customers using safety. Baxter Suzhou not only follow up the quality policy of Baxter headquarters, but also carry out the quality management system of China strictly as well ,At present, more than 560 employees are using the latest manufacturing technology to provide high quality medical products for customers comes from China Taiwan, India, Australia and the Philippines.
我们的理念是注重结果、客户导向；我们的价值观是正直诚实、坦诚沟通、承责力行；我们的激励方式是鼓励创新、奖励优秀。百特致力于成为危重治疗领域的领先企业，期盼更多优秀人才的加入，我们承诺为您提供充满活力的工作和成长环境，与百特共筑未来！