Lois Sim Email & Phone Number

Singapore

Singapore

Singapore

- Review and approval of GMP documents such as electronic batch records, master batch records, equipment use records, environmental monitoring forms and work orders- Apply real time systems to view in process data trends and had an overall understanding of operations in solution preparation, upstream and downstream processes- Knowledge and usage of applications – Manufacturing Execution System (PAS|X), Automation or Distributed Control System (DeltaV), PI Data Historian System (RtReports, PI ProcessBook/ PI Vision), Trackwise System (QMTS: deviation, CA/PA/EV, EN/SICAR, ARA records), Computerized Maintenance Management System (CMMS;Maximo), Sample Manager LIMS, Controlled Documents (CDOCS) and Batch Trace Reporting System (BTRS)- Provides quality oversight for all GMP activities - Participates in on the floor triage and support in root cause investigations for deviations- Review of controlled documents - Support in regulatory inspections- Understanding in single use technologies, strategies in contamination control, environmental monitoring and risk management- Proficient in written and verbal communication skills with ability to communicate and collaborate effectively with the management team and technical staff

- Created recombinant mouse embryonic stem cells for the generation of genetically engineered mouse models- Successfully bred an inducible conditional double knockout mouse line- Making of a mouse monoclonal antibody- Documentation of experimental findings, data analysis

- Perform virological tests : viral isolation, immunoassay, serology- Trained in microscopy to recognize cytopathic effect of viruses in multiple cell lines- Sample processing- Results analysis and detailed reporting in a timely manner- Participated in proficiency testing for internal and external lab audits as part of quality assessment- Record taking during lab meetings and minutes preparation- Participated in journal club