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General Electric Lead Operater in Shanghai, China

Job Description Summary

Create and update SOPs for the related operations. Assist the production shift supervisor to carry out daily operation in high efficiency according to cGMP and GEHC SOPs; to ensure all productions are in repeatable high quality.

The Production Lead Operator is responsible for the production steps including the preparation, filtration, component preparation, filling, capping, tray up & autoclaving at the Injectables Department.

Job Description

RESPONSIBILITIES:

Personal

  • Maintain a safe place of work for his/her responsible area.

  • Monitor Production Operators performance and identify training needs.

  • Ensure staff has been trained appropriately before enrolling the job and the qualification matrix is up to date accordingly.

  • Train the new staff in the area and fill the training record.

  • In conjunction with supervisor, organize operator’s area allocation, overtime and shift when so required. 2. Production

  • Monitor line performance; achieve daily/weekly production targets.

  • Assist shift supervisor to complete departmental goal setting and monitoring the progress by OEEs figures.

  • Participate in the process if necessary.

  • Carry out trend registration in the area and solve the technical problem during production.

  • Input the process data into SAP system within agreed time.

  • Identify and replenish the consumable requirements within his/her own area.

  • Maintain a high level of housekeeping and paperwork standards in adherence with cGMP and GEHC SOPs.

  • Check and review the documentation (batch records, logbooks) is filled in accordance with regulatory requirements. 3. Quality management

  • Be fully trained and competent in cGMP requirements that applicable to his/her responsible area.

  • Assist supervisor to ensure that all documents in their area are current, accurate and comply with cGMP.

  • Area responsible person for control of batch documentation: organizes production arrangements, archiving and retrieval when necessary.

  • Be responsible for deviation and corrective actions following up and implementation.

  • Aim and work in order to eliminate deviations within his/her area.

  • Participate IPC testing. QUALIFICATION/EXPERIENCE:

  • Minimum college or university education and minum2 years experience in the Pharmaceutical/Chemical/food Industry is preferred.

  • Supervisory/team leader experience would be an asset but training will be provided.

  • Good knowledge in English and computer is required.

RESPONSIBILITIES:

Personal

  • Maintain a safe place of work for his/her responsible area.

  • Monitor Production Operators performance and identify training needs.

  • Ensure staff has been trained appropriately before enrolling the job and the qualification matrix is up to date accordingly.

  • Train the new staff in the area and fill the training record.

  • In conjunction with supervisor, organize operator’s area allocation, overtime and shift when so required. 2. Production

  • Monitor line performance; achieve daily/weekly production targets.

  • Assist shift supervisor to complete departmental goal setting and monitoring the progress by OEEs figures.

  • Participate in the process if necessary.

  • Carry out trend registration in the area and solve the technical problem during production.

  • Input the process data into SAP system within agreed time.

  • Identify and replenish the consumable requirements within his/her own area.

  • Maintain a high level of housekeeping and paperwork standards in adherence with cGMP and GEHC SOPs.

  • Check and review the documentation (batch records, logbooks) is filled in accordance with regulatory requirements. 3. Quality management

  • Be fully trained and competent in cGMP requirements that applicable to his/her responsible area.

  • Assist supervisor to ensure that all documents in their area are current, accurate and comply with cGMP.

  • Area responsible person for control of batch documentation: organizes production arrangements, archiving and retrieval when necessary.

  • Be responsible for deviation and corrective actions following up and implementation.

  • Aim and work in order to eliminate deviations within his/her area.

  • Participate IPC testing. QUALIFICATION/EXPERIENCE:

  • Minimum college or university education and minum2 years experience in the Pharmaceutical/Chemical/food Industry is preferred.

  • Supervisory/team leader experience would be an asset but training will be provided.

  • Good knowledge in English and computer is required.

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