验证主管岗位职责（优选3篇）

验证主管岗位职责

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。

验证主管岗位职责：qc验证主管

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 external) and the periodic verifications (internal or external) 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 external) (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 external 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 labs si

required skills:

1. bachelor degree in relevant;

2. with 5-10 years professional experience 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.

验证主管岗位职责：产品验证主管

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。