JOB SUMMARY
To establish and maintain an excellent quality control performance in microbial laboratory to meet business requirement. Assist to schedule, coordinate, and supervise all microbial lab activities. Protocol preparing and technical report for variety existing products/process and any changing. Interface with a variety of disciplines to evaluate applicability of existing method. Leading strong routine investigation and non-conformance of routine testing. Evaluating trend environmental monitoring and microbial identification data quarterly and annually.
Lab activity management, meet business requirement. Document and protocol preparing and reviewing.
Manage laboratory’s testing and activities that ensure the release of testing as per production and Logistics’ need.
Testing data, report and trend data review. Ensure all the operation is according to site SOP and guide without compliance concern.
Trouble shooting and lead LIR, Deviation and Change Control. Be qualified with QTS and LIMS
Conduct the further investigation on “OOS” or “Atypical Results” and track CAPA / Commitments.
Ensuring compliance to existing specification and standard procedure.
Familiar with analytical core technology and participate in the projects from Corporate/Region to site, such as Lean Lab CDAS, LIMS.
Prepare and review Micro Lab validation or qualification protocols & conclusive reports on “Testing Methods”, “Equipment/Instruments”…etc.
Conduct method transfer among sites
Conduct Micro Lab training