-Manage and Maintain Instrument/Equipment Life Cycle: purchasing, installation/qualification, calibration/performance check, troubleshooting and decommission.
-For new instrument/equipment procurement, manage the relative activities, i.e. technical and beneficial survey according to laboratory requirement, purchasing related activities (e.g. manage CapEx, request quotation, apply for purchasing request and confirm invoice), installation/operation/performance qualification (IOPQ), related documents (e.g. URS, FRS, IOPQ protocol/report, VSR, TM, SOP).
-Manage periodical calibration/performance check/preventive maintenance for laboratory instruments/equipment.
-Maintain periodical schedule in SAP, including all calibration/performance check/preventive maintenance, instrument periodic review and data restore verification.
-Maintain and assure the currency and accuracy of all in-house standards used for the calibration/performance check, including gauges, device, volumetric unit, Temp probe, standard weight, calibration kit and chemical standards.
-Maintain instrument relevant SOPs/Logbooks/Forms, including initiate and review.
-Manage the documents related to instrument/equipment, such as brochure, technical information, user manual, safety data sheet, all protocols, reports and logbooks.
-Manage instrument/equipment related change controls, e.g. instrument/equipment moves, upgrades, document revision or any other critical changes by appropriate SOPs.
-Manage instrument/equipment troubleshooting/repair/replacement through Out of Service Notification (OOSN). Pro-actively coordinate to minimize the impact of such activity on lab operations.
-Conduct instrument related investigations/impact assessment in case any instrument/equipment fails the qualification/performance verification.
-Manage and maintain computer system validation (CSV) related activities, e.g. user privilege and account management, periodical review, data backup/archiving and restore verification.
-Co-ordinate and ensure that instrument vendors and contract service are providing prompt, high quality services with respect to installation, qualification, repair and maintenance.
-Maintain QC lab instrument/equipment master list.
-Prepare related information and/or generate documents for SOP and GMP regulatory required documents, such as annual product report and instrument/equipment annual report.
-Contribute, as a Subject Matter Expert (SME) for instrument/equipment, to drive continuous improvements for the life cycle procedures.
-Train and develop laboratory end users to improve their proficiency and expertise in the operation of instrument/equipment and their related operating software.
-Implement LIMS project.
-Other duties as assigned by the supervisors or company.
