1.      工作内容CONTENT

1.1.    

负责编写设施设备用户需求标准（URS），提出设备采购申请。

Responsible for drafting User Requirement Specification (URS) of facilities and equipment and proposing the application for equipment purchasing.

1.2.    

负责设备及其备件验收，并撰写设备相关SOP。

Responsible for equipment and spare parts acceptance and preparing SOPs related equipment.

1.3.    

负责设备维护保养计划的制定。

Responsible for making equipment maintenance plans.

1.4.    

负责设备日常维护、维修和报废。

Responsible for daily maintenance and scrapping of equipment.

1.5.    

负责设备技术档案的收集及管理。

Responsible for collecting and managing equipment technical files.

1.6.    

负责建立GMP制剂中试车间设备/仪表台账。

Responsible for setting up equipment/instrument list.

1.7.    

负责GMP制剂中试车间仪器/仪表的校验。

Responsible for the calibration of instrument.

1.8.    

负责设备备品备件的选购。

Responsible for selective purchasing equipment spare parts.

1.9.    

负责设备突发问题的协调和解决。

Responsible for coordinating and solving equipment emergent problems.

1.10.  

调查和评估设备相关偏差，并上报QA。

Investigate and evaluate the deviations related to equipment, and report to QA.

1.11.  

对设备和厂房的变更做出评估。

Evaluate the changes of equipment and workshop.

1.12.  

负责设备维护组管理工作。

Responsible for the management of the Equipment Maintenance group.

1.13.  

完成其他相关工作。

Execute other related tasks.

1.      教育背景和任职资格EDUCATION BACKGROUND AND QUALIFICATION

1.1.    

药学、机电、机械或其他相关专业专科及以上学历。

College degree or above in pharmaceutical, electromechanical, mechanical or other related majors.

1.2.    

3年以上制药或相关行业设备安装、维修及保养工作经验或一年以上同岗位管理工作经验。

More than 3 years’ experience in equipment installation, repair and maintenance in pharmaceutical or related industries, or more than one year’s experience in the management of the same position.

1.3.    

接受过GMP相关知识的培训。

Have been trained in GMP related knowledge.

1.4.    

具备设备验证、仪器仪表计量及相关工作经验。

Have the experience in equipment validation, instrumentation metrology and related work.

1.5.    

具备专业技术能力，具备专业的机械设备安装、维修以及保养知识，具备熟练的设备维修及保养操作技能。

Have professional technical ability, have professional knowledge of mechanical equipment installation, repair and maintenance, and have skillful operational skills of equipment repair and maintenance.

1.6.    

具备较强的问题分析、判断及解决能力。

Have strong ability of problem analysis, judgment and resolution.

1.7.    

具备良好的沟通交流能力。

Have good communication ability.

1.8.    

熟练使用Office、CAD等办公软件。

Skilled in Office, CAD, and other office software.

1.9.    

具备基本英语知识。

Have basic English knowledge.