资深验证工程师(职位编号:10000)
泰事达机电设备(上海)有限公司
- 公司规模:50-150人
- 公司性质:外资(欧美)
- 公司行业:医疗设备/器械 机械/设备/重工
职位信息
- 发布日期:2015-02-13
- 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:大专
- 语言要求:英语熟练
英语精通 - 职位类别:质量管理/测试主管(QA/QC主管) 安全防护
职位描述
Main Functions:
--Prepare, update and execute whole set of qualification documentations. Including:
-QPP (Quality project plan)
-FS(Function Specification)
-DS/DQ(Design Specification/Design Qualification)
-FAT(Factory acceptance test)
-SAT (Site acceptance test.
-IQ(Installation qualification)
-OQ(Operation qualification)
--Internal calibration execution
--Prepare SOP for related operations.
--Work together with electrical engineer to finish equipment testing and FAT qualification performance
--Participate official FAT with the witness of customer.
--Participate the third-part audit.
--Ensure appropriate corrective and preventive actions are initiated and completed.
--Resolve and coordinate the problems related to the assembling with production.
--Providing quality training for the relevant employees.
--Finish other jobs assigned by quality manager.Knowledge:
Essentials:
- Engineering, mechanical background or related. Familiar with GMP, FDA regulations is preferred.
- Over 5years working experience in international manufacturing company relative to pharmaceutical or biological industry on the position QC/QA
- Good knowledge of quality control system. Experience in ISO 9001 & 14001 standards.
- Good knowledge of machining and assembling, be able to read mechanical and electrical drawings.
- Knowledge of measuring equipment calibration and validation.
- Good at trouble shooting and analysis.
- Team work spirit
To be considered:
--Familiar with freeze dryer is preferred.
--Experience on project management is preferred.
--Familiar with HSE is preferred.
Mission:
--Ensure that the finished equipment is fully tested, comply with design requirement and customer expectations.
--Promoting and implement continuous improvement of quality management
Dimensions:
Headcount: Quality manager
Direct: QC
Most relevant relationships:
Internal: All departments (purchasing, production……)
External: Headquarter, suppliers, customer, third party auditor…
Skills:
-Fluent English in written, oral, read
-Good computer skills
Previous experience:
Good relationship both internal and external and communication skills
--Prepare, update and execute whole set of qualification documentations. Including:
-QPP (Quality project plan)
-FS(Function Specification)
-DS/DQ(Design Specification/Design Qualification)
-FAT(Factory acceptance test)
-SAT (Site acceptance test.
-IQ(Installation qualification)
-OQ(Operation qualification)
--Internal calibration execution
--Prepare SOP for related operations.
--Work together with electrical engineer to finish equipment testing and FAT qualification performance
--Participate official FAT with the witness of customer.
--Participate the third-part audit.
--Ensure appropriate corrective and preventive actions are initiated and completed.
--Resolve and coordinate the problems related to the assembling with production.
--Providing quality training for the relevant employees.
--Finish other jobs assigned by quality manager.Knowledge:
Essentials:
- Engineering, mechanical background or related. Familiar with GMP, FDA regulations is preferred.
- Over 5years working experience in international manufacturing company relative to pharmaceutical or biological industry on the position QC/QA
- Good knowledge of quality control system. Experience in ISO 9001 & 14001 standards.
- Good knowledge of machining and assembling, be able to read mechanical and electrical drawings.
- Knowledge of measuring equipment calibration and validation.
- Good at trouble shooting and analysis.
- Team work spirit
To be considered:
--Familiar with freeze dryer is preferred.
--Experience on project management is preferred.
--Familiar with HSE is preferred.
Mission:
--Ensure that the finished equipment is fully tested, comply with design requirement and customer expectations.
--Promoting and implement continuous improvement of quality management
Dimensions:
Headcount: Quality manager
Direct: QC
Most relevant relationships:
Internal: All departments (purchasing, production……)
External: Headquarter, suppliers, customer, third party auditor…
Skills:
-Fluent English in written, oral, read
-Good computer skills
Previous experience:
Good relationship both internal and external and communication skills
公司介绍
公司简介
阿自倍儿泰事达隶属于阿自倍尔集团,总部位于西班牙特拉萨,提供全球具有附加值的解决方案,致力于多样化的技术领域,如生命和健康科学(制药,生物技术和相关行业),科学研究和开发(航空航天,电信和微电子等的研究),以及工业(汽车,家庭和工业冷却,化学品等)。泰事达业务遍及全球100多个国家,并在西班牙、中国、英国和荷兰设有生产基地。
阿自倍儿泰事达机电设备(上海)有限公司成立于2004年,主要提供用于制药、生物科技和实验室的超低温冰箱(-86摄氏度。)、空气净化设备、冻干机、消毒柜、和CIP(在位清洗)设备的制造和服务。
公司致力于为所有员工提供充足的机遇,取得杰出的成绩,同时获得充分的尊重和公平的待遇。
联系: Flora/人力资源部
电话:58093731-812,13818974398
邮箱:fshi@telstar.com
交通:地铁2号线世纪公园站3号口有班车接送
阿自倍儿泰事达隶属于阿自倍尔集团,总部位于西班牙特拉萨,提供全球具有附加值的解决方案,致力于多样化的技术领域,如生命和健康科学(制药,生物技术和相关行业),科学研究和开发(航空航天,电信和微电子等的研究),以及工业(汽车,家庭和工业冷却,化学品等)。泰事达业务遍及全球100多个国家,并在西班牙、中国、英国和荷兰设有生产基地。
阿自倍儿泰事达机电设备(上海)有限公司成立于2004年,主要提供用于制药、生物科技和实验室的超低温冰箱(-86摄氏度。)、空气净化设备、冻干机、消毒柜、和CIP(在位清洗)设备的制造和服务。
公司致力于为所有员工提供充足的机遇,取得杰出的成绩,同时获得充分的尊重和公平的待遇。
联系: Flora/人力资源部
电话:58093731-812,13818974398
邮箱:fshi@telstar.com
交通:地铁2号线世纪公园站3号口有班车接送
联系方式
- Email:fshi@telstar.com
- 公司地址:上班地址:上海市浦东祝桥空港工业区金闻路30号