Validation Engineer验证工程师（欧洲医疗行业独资公司质量部职位，有医药相关行业背景优先考虑）
上海帝博企业管理咨询有限公司
- 公司规模：少于50人
- 公司性质：外资(欧美)
- 公司行业：专业服务(咨询、人力资源、财会)
职位信息
- 发布日期：2012-11-09
- 工作地点：苏州
- 招聘人数：1
- 工作经验：三年以上
- 学历要求：大专
- 职位类别：认证工程师/审核员
职位描述
Validation Engineer验证工程师（欧洲医疗行业独资公司质量部职位，有医药相关行业背景优先考虑）
工作地点：苏州园区
Job Summary and Area of Responsibility
This position will participate execution of approved validation program via independent action, or cooperation with others.
This position will be responsible for guiding and coordinating staff from QC, Prod., ENG of specialists for developing, reviewing,
and execution of Q&V documentation through VMP, DP, IQ, OQ, PQ, URS to maintain processes and equipment in a validated status.
This position will also provide training to user departments on the development and execution of validation protocols.
Major Duties and Performance Standards to be achieved:
support validation supervisor for developing and maintaining VMP and ensure it update to the latest status of plant as necessary
ensure the requirements of CoE and regulatory are fulfilled by creating validation protocol and gap analysis together with user department specialists for
l sterilization validation
l HVAC/clean room validation
l Validation of clean media
l Process validation
l Cleaning validation
l holding time
l Qualification of equipments
l Computer system validation
l Validation concerning temperature measurement
l Q&V as necessary to the change control
Implement risk analysis with FMEA tool with teamwork of relevant departments, renew system impact assessment under instruction.
coordinate the execution of validation activities and compile validation report for evaluation of the required validation status of clean media, HVAC/clean room, process, equipment/devices
Look into the latest validation requirement and make gap analysis refer to the current status
development of SOP’s, change control and resolving deviations in regarding to Q&V
ensure Q&V document compliance and completion of required Q&V in the due time
Education Required:
University Graduate or above
- chemical/electoral mechanical engineering
- pharmaceutical engineering
- other validation relevant
Experience/Knowledge Required:
- more than 3 years with validation in infusion production
- experience with GxP
- Good team work awareness
- well knowing Microsoft Office
Special Skills/Abilities Required
English reading, writing and speaking
工作地点：苏州园区
Job Summary and Area of Responsibility
This position will participate execution of approved validation program via independent action, or cooperation with others.
This position will be responsible for guiding and coordinating staff from QC, Prod., ENG of specialists for developing, reviewing,
and execution of Q&V documentation through VMP, DP, IQ, OQ, PQ, URS to maintain processes and equipment in a validated status.
This position will also provide training to user departments on the development and execution of validation protocols.
Major Duties and Performance Standards to be achieved:
support validation supervisor for developing and maintaining VMP and ensure it update to the latest status of plant as necessary
ensure the requirements of CoE and regulatory are fulfilled by creating validation protocol and gap analysis together with user department specialists for
l sterilization validation
l HVAC/clean room validation
l Validation of clean media
l Process validation
l Cleaning validation
l holding time
l Qualification of equipments
l Computer system validation
l Validation concerning temperature measurement
l Q&V as necessary to the change control
Implement risk analysis with FMEA tool with teamwork of relevant departments, renew system impact assessment under instruction.
coordinate the execution of validation activities and compile validation report for evaluation of the required validation status of clean media, HVAC/clean room, process, equipment/devices
Look into the latest validation requirement and make gap analysis refer to the current status
development of SOP’s, change control and resolving deviations in regarding to Q&V
ensure Q&V document compliance and completion of required Q&V in the due time
Education Required:
University Graduate or above
- chemical/electoral mechanical engineering
- pharmaceutical engineering
- other validation relevant
Experience/Knowledge Required:
- more than 3 years with validation in infusion production
- experience with GxP
- Good team work awareness
- well knowing Microsoft Office
Special Skills/Abilities Required
English reading, writing and speaking
公司介绍
公司微博：******************/dbtalent?ref=http%3A%2F%***********%2F2674989551%2Ffans%3Ftopnav%3D11
公司QQ：1652479807
公司msn：workdbtalent@hotmail.com
公司QQ：1652479807
公司msn：workdbtalent@hotmail.com
联系方式
- Email：workdbtalent@hotmail.com
- 电话：13701722965