QA主管
上海铂锦诊断用品有限公司
- 公司规模：50-150人
- 公司性质：外资(非欧美)
- 公司行业：医疗设备/器械 制药/生物工程
职位信息
- 发布日期：2012-11-13
- 工作地点：上海-浦东新区
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：本科
- 职位类别：医疗器械生产/质量管理
职位描述
岗位职责：
1、 负责公司质量体系的建立和完善、公司产品全过程的质量控制和公司质量文件的审核，确认验证的计划及组织；
2、 依据产品质量监控计划，负责生产现场的质量监督工作和批记录的审核。
3、 负责和协调注册产品标准的制定和修订，负责产品的注册检验、注册资料的准备和申报等工作并及时跟进各项工作的进度。保持与检测中心、审评中心等SFDA相关部门的良好沟通。
岗位要求：
1、生物医药或医学检验相关专业，本科及以上学历。
2、3年以上医药或医疗器械行业QA工作经验，持有医疗器械内审员证书。
3、精通GMP知识，并熟练应用GMP对产品质量进行控制。
4、 熟悉医疗器械质量管理体系管理，熟悉医疗器械iso13485质量管理标准。
5、 熟悉医药行业相关法律法规及政策，对注册法规有全面的了解； 熟悉医疗器械和药品注册报批的工作流程，可熟练操作相关业务；具备对申报资料进行审核的能力。
6、 踏实敬业、认真仔细，有原则性。
7、 具备一定的沟通协调与管理能力。
1、 负责公司质量体系的建立和完善、公司产品全过程的质量控制和公司质量文件的审核，确认验证的计划及组织；
2、 依据产品质量监控计划，负责生产现场的质量监督工作和批记录的审核。
3、 负责和协调注册产品标准的制定和修订，负责产品的注册检验、注册资料的准备和申报等工作并及时跟进各项工作的进度。保持与检测中心、审评中心等SFDA相关部门的良好沟通。
岗位要求：
1、生物医药或医学检验相关专业，本科及以上学历。
2、3年以上医药或医疗器械行业QA工作经验，持有医疗器械内审员证书。
3、精通GMP知识，并熟练应用GMP对产品质量进行控制。
4、 熟悉医疗器械质量管理体系管理，熟悉医疗器械iso13485质量管理标准。
5、 熟悉医药行业相关法律法规及政策，对注册法规有全面的了解； 熟悉医疗器械和药品注册报批的工作流程，可熟练操作相关业务；具备对申报资料进行审核的能力。
6、 踏实敬业、认真仔细，有原则性。
7、 具备一定的沟通协调与管理能力。
公司介绍
上海铂锦诊断用品有限公司（www.beckin.com.cn）是以研究为基础，以创新驱动的专业生产临床生化诊断试剂的外商独资企业，坐落在上海浦东新区的国家级医疗器械产业高科技园、国家火炬计划医疗器械产业基地、国家“863计划”上海医疗器械产业基地、上海生物医药产业基地——“中国医谷”上海国际医学园区内。目前，公司的研发、生产大楼面积达2600余平方米，拥有先进的生产设备和检测仪器，建立了国内一流的研发生产技术平台。
公司自成立以来，凭借高标准的操作规范流程、专业严谨的生产技术人员、稳定均衡的生产条件，不断向临床诊断领域的研究人员、医师、患者、医院和实验室提供多样化的高端生化诊断试剂和服务。产品涵盖血脂、肝功、肾功、心肌酶、胰腺炎、糖尿病检测等多方面,适用于多种进口和国产全自动生化分析仪，现已有55项产品获得医疗器械产品注册证。
我们致力于为客户提供高品质的产品和服务，为客户和社会创造价值。同时，公司将不断引进推出紧跟国际医学发展和医院检验需求的新产品，不断完善产品结构和拓宽服务领域，与客户分享技术和市场成果，实现共赢!
地址（研发生产和营销）：上海市浦东新区天雄路588弄25号楼（上海国际医学园区 医谷现代商务园25号楼）
工厂电话：021-38019588 传真：021-38019221
市场营销中心 电话：021-58306208 传真：021-50818997
Shanghai BangQi Bio-engineering Co., Ltd. is a Specialization Group based on the operation of a modern mode. And as its subsidiary, Shanghai Beckin Diagnostics Co.,Ltd is an exclusively foreign-owned enterprise, specializing in the production of clinical and biochemical diagnostic reagents, located in the Shanghai International Medical Zone, assessed as the national medical appliance industry cluster, the National Torch Plan medical equipment industry base, the National “863 Program” medical instrument industry base in Shanghai, the national biomedical industry base in Shanghai——“China Medical Valley”. Through years of successful construction, our R&D and production building covers an area of 3800m2, and we have world-class chemical and biological production equipments and detection equipments, highly sophisticated researcher, and advanced production technology.
Since its inception, we have constantly provided a variety of biochemical diagnostic reagent and service to the researchers in the fields of clinical diagnostics, physicians, patients, hospitals and laboratories. Nowadays, the products include blood lipids, liver function, pancreatitis, diabetes testing and other aspects, suitable for a variety of imported and domestic automatic biochemical analyzer, there are already 55 products have medical device product registration card.
Our goal is being the leader in the field of clinical and biochemical diagnostic. In the future, BangQi will continue to organize product in strict accordance with the GMP standard advanced and perfect production quality assurance system, by virtue of the operation of a high standard specification process, rigorous professional and technical personnel, and stable equilibrium production conditions. Meanwhile, we will constantly keep up the introduction of the introduction of international medical development and the needs of a hospital for examination of new products, and constantly improve the product structure and expand the service areas, so as to share the technical and market achievements with the customers and realize double-win.
公司自成立以来，凭借高标准的操作规范流程、专业严谨的生产技术人员、稳定均衡的生产条件，不断向临床诊断领域的研究人员、医师、患者、医院和实验室提供多样化的高端生化诊断试剂和服务。产品涵盖血脂、肝功、肾功、心肌酶、胰腺炎、糖尿病检测等多方面,适用于多种进口和国产全自动生化分析仪，现已有55项产品获得医疗器械产品注册证。
我们致力于为客户提供高品质的产品和服务，为客户和社会创造价值。同时，公司将不断引进推出紧跟国际医学发展和医院检验需求的新产品，不断完善产品结构和拓宽服务领域，与客户分享技术和市场成果，实现共赢!
地址（研发生产和营销）：上海市浦东新区天雄路588弄25号楼（上海国际医学园区 医谷现代商务园25号楼）
工厂电话：021-38019588 传真：021-38019221
市场营销中心 电话：021-58306208 传真：021-50818997
Shanghai BangQi Bio-engineering Co., Ltd. is a Specialization Group based on the operation of a modern mode. And as its subsidiary, Shanghai Beckin Diagnostics Co.,Ltd is an exclusively foreign-owned enterprise, specializing in the production of clinical and biochemical diagnostic reagents, located in the Shanghai International Medical Zone, assessed as the national medical appliance industry cluster, the National Torch Plan medical equipment industry base, the National “863 Program” medical instrument industry base in Shanghai, the national biomedical industry base in Shanghai——“China Medical Valley”. Through years of successful construction, our R&D and production building covers an area of 3800m2, and we have world-class chemical and biological production equipments and detection equipments, highly sophisticated researcher, and advanced production technology.
Since its inception, we have constantly provided a variety of biochemical diagnostic reagent and service to the researchers in the fields of clinical diagnostics, physicians, patients, hospitals and laboratories. Nowadays, the products include blood lipids, liver function, pancreatitis, diabetes testing and other aspects, suitable for a variety of imported and domestic automatic biochemical analyzer, there are already 55 products have medical device product registration card.
Our goal is being the leader in the field of clinical and biochemical diagnostic. In the future, BangQi will continue to organize product in strict accordance with the GMP standard advanced and perfect production quality assurance system, by virtue of the operation of a high standard specification process, rigorous professional and technical personnel, and stable equilibrium production conditions. Meanwhile, we will constantly keep up the introduction of the introduction of international medical development and the needs of a hospital for examination of new products, and constantly improve the product structure and expand the service areas, so as to share the technical and market achievements with the customers and realize double-win.