職位描述
Key Responsibilities主要崗位職責(zé):
Calibration Part:
? Issue the calibration master schedule at the beginning of every year.
? Create accurate and timely calibration forecast
? Calibration budget planning and R&M tracking.
? Ensure all instruments can be used in their due date and run well.
? Stakeholder management including national and local calibration institute.
? Ensure all instruments calibration is compliance to GSK GMP, EHS, Engineering standards and local code..
? Ensure Maintenance activities in compliance with EHS, Engineering, GMP and legislation requirement.
? Handle the application of instruments failure, stopping using, disposal etc.
? Update the calibration database in time.
? Develop calibration SOPs.
? Manage all calibration documentations including calibration certificates and testing report.
? Support other departments complete equipment validation.
? Deliver calibration training for site
? Apply proper tools in incident investigation and CAPA.
? Calibration testing report verification
? Network supporting in term of calibration knowledge and experience
? Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
Maintenance Part:
? Maximize equipment’s life span and efficiency through effective management of Maintenance system.
? Ensure Maintenance activities compliance with EHS,GMP, Business requirement and Global Engineering Standards.
? PPM and NPPM maintenance in CMMS
? Overview Maintenance document management.
? Overview Maintenance management strategy, policy, procedure develops, review and update and internal audit.
? To overview Engineering Compliance management
? Organize Engineering annual RBM review
? Maintain Engineering equipment and facility list
? Understand and comply with the applicable local regulations of Quality, EHS and others, GSK standards for QMS, EHSS etc. and company policy. Adherence to standard operating procedures.
Specialized Knowledge 專業(yè)知識:
? Bachelor or above degree in precision-instrument or calibration, whit local government qualified for calibration.
? Understanding Preventive Maintenance principle and implementation.
? 8 years above operational experience
? Understanding Calibration principle and implementation.
? Engineering background with knowledge and experience about calibration/or pharmaceutical production & laboratory instrument /production equipment and facility/utility for Pharmaceutical industry. Be professional at metrology.
? Have systematic thinking on calibration, instruments management, preventive maintenance and spare part management
? Familiar with CMMS system with hands on experience
? Team working and positive working attitude.
? Good communication, English ( CET4 above) and computer skills, Good English in reading, speaking and writing
? Excellent written and oral communication skills.
? Demonstrated initiative and analytical problem solving skill.
? Project management skills.
