Operator III

Education Background: 教育背景

3-yr college degree or similar education background in microbiology, mechanical engineering, manufacturing engineering, chemistry, pharmacist, bioscience, or above.  微生物、机械工程、制造工程、化学、药剂学、生物学大专毕业或以上学历。

Computer literacy. 具备基本计算机使用技能。

Basic English skill. 具备基本英语技能。

Professional Experience专业经验:

1-3 years of production experience in pharmaceutical industry with cGMP regulated aseptic process or in life science industry.  具有一至三年在有cGMP要求的无菌生产流程的药厂或者生命科学行业企业的工作经验。

Equipment experience including hardware and software is preferable. 最好有生产设备软、硬件操作的经验。

Experience in clean room or aseptic area is preferable. 最好有在洁净空间或无菌区域生产的工作经验。

Prefer to have gotten training which includes thorough understanding of mechanical, electrical and control system within engineering, pharmaceutical or equivalent industries. 最好接受过工程、制药或相关行业内机械、电气、控制系统的培训。

Knowledge of cGMP is preferable. 最好具备cGMP的知识。

Key areas of responsibility 主要工作职责:

Operator is the key contributor to following indicators of AP production: 生产操作员负责无菌生产的如下任务指标：

Execute production schedule/cycle plan 执行生产计划，完成生产订单

Safe working environment 安全的生产环境

Process lead time 过程交货时间

Input delays 记录生产延迟

Main Job Tasks 主要工作任务:     

Perform production activities on filling line following SOP requirement. 遵循标准操作流程（SOP）的要求执行罐装生产线的生产活动。

Finish training on time. 按时完成培训。

Record BPR according to GMP requirement. 按照GMP的要求完成批生产记录。

Incident investigation. 事故调查

PAS-X operation. 执行生产过程中PAS-X系统的正确操作。

Perform cleaning activities in production area. 在生产区域执行清洁工作。

BPR reviewing.检查批生产记录文件。

Follow EHS requirement to ensure safety. 遵循EHS的要求确保工作安全。

Housekeeping and 5S maintenance.维护生产区域5S