Calibration Supervisor - Wuhan
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.
- Site Safety
- Contributing to the safe operation of JHL Biotech facilities through personal initiative and adherence with Company procedures.
- Zero lost-time injuries
- 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.
- Preparing standard operating procedures and associated records for calibration activities
- Complying with, and continuously improving, the Company Quality Management System.
- Reviewing instrument specifications for compliance with company quality standards and performance criteria.
- 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.