- 目录
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第1篇验证主管岗位职责 第2篇整机集成及验证主管工程师岗位职责描述岗位要求 第3篇产品验证主管岗位职责 第4篇qc验证主管岗位职责 第5篇qc验证主管岗位职责任职要求 第6篇控制系统集成验证岗主管工程师岗位职责描述岗位要求
第1篇 qc验证主管岗位职责任职要求
qc验证主管岗位职责
job summary:
ensure the maintenance and qualification of the analytical and metrological equipment of the novacyl quality control laboratory;
support non-routine analytic activities such as analytical validation, analytical transfers and method troubleshooting;
manage the analysts in charge of qualification and validation activities (resources from the hplc and physical chemistry laboratory seconded to the qualification/validation projects).
mains missions :
maintenance/qualification of laboratory equipment ;
management of analytical transfer and validations.
mission 1: maintenance
organizes the preventive maintenance (internal or e_ternal) and the periodic verifications (internal or e_ternal) of the equipment of the laboratory (planning / follow-up of the supplier) in the respect of the deadlines and costs
organizes the curative maintenance of laboratory equipment during breakdowns (internal or e_ternal) (planning / monitoring of service providers)
manages stocks of spare parts needed for first-level maintenance
represents the maintenance pole during audits and inspections by the authorities
supports laboratory technicians in case of equipment problems
organizes calibration/verification of standards dedicated to equipment verification by e_ternal agencies
mission 2: qualification laboratory equipment
write the equipment qualification documentation for the laboratory (urs, protocols ....)
organize qualification by suppliers
conduct and / or organize additional tests not performed by suppliers (internal or outsourced)
write the equipment usage documentation (operating modes, logbooks ...)
presents qualification records during audits and inspections by the authorities
ensures the training of technicians in the use of equipment
organizes equipment supplier qualification
participates in the choice of laboratory equipment and software
mission 3: coordination of analytical transfer, validations and troubleshooting activities
supports the technicians in case of analytical problem, technical oos, technical question write the study protocols/report for the laboratory off stream activities (analytical validation, transfer ...) organise with the laboratory staff the studies for off stream activities (analytical validation, transfer ...)
participates in the creation / modification of the working documentation (analytical methods, work instructions…
mission 4: laboratory life
participates to various meetings related to the operation of the service (daily, monthly ...) leads actions to improve the operation of the maintenance center and the laboratory. defines with the manager the investment strategy for laboratory equipment is the system administrator of the lab's si
required skills:
1. bachelor degree in relevant;
2. with 5-10 years professional e_perience in a quality control laboratory in a gmp environment;
3. spoken english is a plus;
4. good knowledge of the standards applicable to the laboratory (pharmacopoeia, .ich...);
5. good understanding of equipment and analytical laboratory techniques (titration, gc, hplc, spectroscopy, karl fischer, ....);
6. knowledge of software related to laboratory equipment.
qc验证主管岗位
第2篇 验证主管岗位职责
验证主管 安礼特(上海)医药科技有限公司 安礼特(上海)医药科技有限公司,安礼特 五、验证主管1-2人
岗位职责
1、参与生产系统验证,计算机化系统验证项目实施
2、制定验证总计划/风险评估/设计文件/验证文件/验证报告/追溯矩阵文件
3、参与验证过程中的偏差、变更处理。
岗位要求:
1、具有药学相关专业本科以上学历;
2、有参与建立验证体系的经验。
3、制定过gmp验证总计划和验证实施计划。
4、有固体制剂设备、公用系统确认经验
5、熟悉验证过的主要设备原理。
6、懂计算机化系统验证者优先
7、具有基础的制药装备自动化、应用软件基础知识。
第3篇 控制系统集成验证岗主管工程师岗位职责描述岗位要求
职位描述:
职责描述:
'1.负责实施控制系统硬件在回路、半物理等系统的集成与验证试验工作,以及相应的技术文件编制。
2.参与控制系统硬件在回路、半物理等控制系统总体相关集成验证平台的建设及协调,以及相应技术文件编制工作。
3.参与控制系统集成验证专业相关流程、工具、标准、规范和数据库等工作
4.参与组织制定控制系统集成验证的技术发展路线,以及基础技术研究'
职位要求:
'1.控制系统总体或控制系统试验设计师任职5年(硕士研究生3年,博士研究生2年)及以上,具有caac/faa适航认证相关经验或知识者优先。
2.掌握控制系统设计、控制系统试验基本流程和方法;
3.能熟练阅读本专业英文资料,能用英语撰写技术报告或技术论文,有一定的英语口语交流能力,能较好地理解英文技术讲座和报告;
4.熟练掌握matlab/simulink、c/c++、labview等控制系统建模与仿真软件以及控制系统试验技术。'
第4篇 产品验证主管岗位职责
实验室主管+产品验证 美埃(中国)环境净化有限公司 中山美埃净化技术有限公司,美埃职责描述:
1、 新开发、改进产品的性能、可靠性的实验验证和评价;
2、 针对售后问题进行产品、关键元器件市场投诉问题分析;
3、 产品新引进风机、电路板等关键资材对整机系统的影响评估和实验验证;
4、 协助及跟进完善整机整改流程;
5、 根据市场及售后问题完善评价体系、标准制度、体系建设;1、 新开发、改进产品的性能、可靠性的实验验证和评价;
6、全面管理实验室的日常工作,合理安排及协调好日常测试任务;
7、熟悉实验室测试仪器和装置,对实验结果进行分析,解释;
8、熟悉专业领域内各类测试标准、产品标准,熟悉各类样品处理方法和测试分析方法,开发新测试方法;
9、对实验室人员进行有效管理,并协调好各部门间的关系,使工作顺畅进行;对实验室人员的技术水平提高进行培训和考核;
任职要求:
1、本科以上,机电、暖通或相近专业;环境工程、化学分析类相关专业
2、具备相关专业产品评价3年以上工作经验;
3、熟练操作电脑、office、autocad等绘图软件;
4、有家电行业工作经验者优先考虑;
5、了解第三方测试;
有cnas实验室认证经验,有环境、空气净化产品测试经验者优先。
第5篇 整机集成及验证主管工程师岗位职责描述岗位要求
职位描述:
职责描述:
1. 协助开展发动机研制需求分析、总要求的编制
2. 协助开展发动机研制型号规范的编制
3. 协助开展发动机验证计划的编制
4. 协助开展设计过程、与飞机集成等过程的飞/发技术协调
5. 协助开展试验总体策划与试验安排,试验方案制定等试验总体相关工作
6. 协助开展试验实施过程中的技术协调和试验数据管理
7. 协助开展发动机设计需求管理
8. 协助开展本专业设计体系建设
职位要求:
1. 总体设计设计师任职3年以上,有总体设计、系统工程工作经验。
2. 航空宇航推进专业、航空发动机专业等
3. 全日制大学本科及以上学历
4. 具备航空发动机专业知识、系统工程专业知识
5. 具有中级(工程师)职称以上者优先
6. 能熟练阅读本专业英文资料,能用英语撰写技术报告或技术论文,有一定的英语口语交流能力,能较好地理解英文技术讲座和报告
第6篇 qc验证主管岗位职责
qc validation/qualification supervisor仪器验证主管 诺化仕(无锡)制药有限公司 诺化仕(无锡)制药有限公司,诺化仕,诺化仕 job summary:
•ensure the maintenance and qualification of the analytical and metrological equipment of the novacyl quality control laboratory;
•support non-routine analytic activities such as analytical validation, analytical transfers and method troubleshooting;
•manage the analysts in charge of qualification and validation activities (resources from the hplc and physical chemistry laboratory seconded to the qualification/validation projects).
mains missions :
•maintenance/qualification of laboratory equipment ;
•management of analytical transfer and validations.
mission 1: maintenance
organizes the preventive maintenance (internal or e_ternal) and the periodic verifications (internal or e_ternal) of the equipment of the laboratory (planning / follow-up of the supplier) in the respect of the deadlines and costs
organizes the curative maintenance of laboratory equipment during breakdowns (internal or e_ternal) (planning / monitoring of service providers)
manages stocks of spare parts needed for first-level maintenance
represents the maintenance pole during audits and inspections by the authorities
supports laboratory technicians in case of equipment problems
organizes calibration/verification of standards dedicated to equipment verification by e_ternal agencies
mission 2: qualification laboratory equipment
write the equipment qualification documentation for the laboratory (urs, protocols ....)
organize qualification by suppliers
conduct and / or organize additional tests not performed by suppliers (internal or outsourced)
write the equipment usage documentation (operating modes, logbooks ...)
presents qualification records during audits and inspections by the authorities
ensures the training of technicians in the use of equipment
organizes equipment supplier qualification
participates in the choice of laboratory equipment and software
mission 3: coordination of analytical transfer, validations and troubleshooting activities
supports the technicians in case of analytical problem, technical oos, technical question write the study protocols/report for the laboratory off stream activities (analytical validation, transfer ...) organise with the laboratory staff the studies for off stream activities (analytical validation, transfer ...)
participates in the creation / modification of the working documentation (analytical methods, work instructions…
mission 4: laboratory life
participates to various meetings related to the operation of the service (daily, monthly ...) leads actions to improve the operation of the maintenance center and the laboratory. defines with the manager the investment strategy for laboratory equipment is the system administrator of the lab's si
required skills:
1. bachelor degree in relevant;
2. with 5-10 years professional e_perience in a quality control laboratory in a gmp environment;
3. spoken english is a plus;
4. good knowledge of the standards applicable to the laboratory (pharmacopoeia, .ich...);
5. good understanding of equipment and analytical laboratory techniques (titration, gc, hplc, spectroscopy, karl fischer, ....);
6. knowledge of software related to laboratory equipment.