岗位职责： 1. Response the national regulation and corporate policy compliance. 负责国家法规与总部政策在工厂的合规性。 2. Responsible for COI program implementation for corporate quality documents.负责总部质量文件的程序符合性的实施。 3. Assist RA to complete product registration in the plant. Keep good communication with the government. 协助RA 完成产品注册。与法规相关政府机构保持良好沟通。 4. Document center and system management. 文件中心及文件系统管理。 5. External Inspection and Internal Audit内外部审核 6. Customer complaint handling and customer satisfaction improvement. 管理客户投诉及客户满意度提升。 7. Nonconformance, Change Control, Validation and supplier management. 偏差，变更，验证及供应商管理。 8. Plant data integrity management. 数据完整性管理 9. Organize monthly MR quarterly meeting and track related actions. 组织召开月度季度管理评审会议，并追踪相关措施。 10. Motivate, train and counsel subordinates, actively promote teamwork for continuous improvement. 激励、培训并指导下属的工作，持续不断地提倡团队精神。 11. Prepare and maintain budget for QS and RA. 准备并实施体系及注册的预算。 12. Other tasks assigned by manager. 完成经理委派的其它任务。 职位要求： 1. Bachelor or above degree in medical, science or related field. 医疗、工科或相关专业本科及以上。 2. At least 7 years quality experience in the pharmaceutical or related environment. 至少7年在药品或相关企业从事与质量有关的工作。 3. Experience in pharmaceutical/medical device, food & cosmetics industry is preferred. 药厂、医疗设备、食品、化妆品工作经历优先。 4. Licensed pharmacist preferred。 执业药师优先。 5. Familiar with medical device, pharmaceutical laws, internal and international standards, such as GMP, QSR 820 and ISO 13485; 熟悉医疗器械及药品法规，国内外行业规范，如中国GMP，美国FDA要求及13485要求等； 6. Skilled in process quality control, validation, change control, CAPA management and so on. 具备熟练的质量过程控制，验证，变更及偏差等管理能力； 7. Active, innovative, good teamwork, people management and communication skill; 积极主动，创新，具有良好的团队合作，人员管理及沟通技巧；。 8. Good English language ability and good computer skill. 良好的英文和计算机能力。
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，是最早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第一家独资工厂，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，确保我们的产品以最高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、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！
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