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Calibration Supervisor - Wuhan

Summary

Full time responsibility for calibration of the critical instrumentation on the global-standard equipment of the JHL Biotech facilities in Taiwan.  This function is responsible for both the Centre of Excellence in Chubei :

  • Calibration of critical instruments and maintaining test equipment
  • Active participation in the development and implementation of the Company Quality Management System with specific responsibility for calibration processes.
  • General support of cross-functional Engineering Department.

Job Responsibilities

 

  • Site Safety
    • Contributing to the safe operation of JHL Biotech facilities through personal initiative and adherence with Company procedures.
    • Zero lost-time injuries 
  • Calibration
    • Maintaining the calibrated state of critical instruments and test equipment in compliance with Good Manufacturing Practice (GMP).
    • Preparing and managing the register of critical instruments
    • Documenting calibration requirements for critical instruments and systems in collaboration with system users.
    • Preparing calibration reports and status indicators
    • Managing primary and secondary reference standards
    • Managing calibration equipment
    • Selecting and purchasing equipment and consumables required to perform calibration activities. 
  • Quality
    • Preparing standard operating procedures and associated records for calibration activities
    • Complying with, and continuously improving, the Company Quality Management System. 
  • Design
    • Reviewing instrument specifications for compliance with company quality standards and performance criteria. 
  • Management
    • Providing technical and financial input to capital expenditure requests for site improvement and renovation projects.
    • Supervising specialist calibration contractors.
    • Preparing weekly and monthly progress reports.
    • Contributing positively to Company morale.
    • Future transfer of validation processes and support of validation activities of other Company facilities.

Job Qualifications (Education, Certifications, Experience)

  • Diploma or B.E. (preferably Mechanical or Electrical) plus a minimum of 5 years experience in calibration within pharmaceutical or medical device industries
  • or at least 8 years of industry experience in calibration in the healthcare, food, or semi-conductor industries.
  • Preferably experienced in operation of pharmaceutical facilities and exposure to facility start-up.
  • Confident in hands-on manipulation of sensitive instruments and test equipment.
  • Sound knowledge of Good Engineering Practices encompassing documentation and operation of pharmaceutical facilities.
  • Sound Understanding of Good Manufacturing Practice (GMP)
  • Familiar with ISPE GAMP Good Practice Guide for Calibration Management
  • Familiar with ISO17025 and ISO10012
  • Advanced document writing skills using MS Office suite
  • Eye for detail and preference to work in highly structured manner.
  • Strong communication skills in English and Chinese to engage with personnel across the Company and service providers including understanding of technical documentation in English.