The QC gLIMS Administrator will be responsible for coordinating, facilitating, and undertaking activities pertaining to Thermo Fisher Sample Manager LIMS system (gLIMS.) The QC gLIMS Administrator will build, develop and maintain LIMS templates and be involved in troubleshooting as required. This role will support The Quality Control team.
Building, testing, verifying, transferring, reviewing and activation of all data required for Master Data Load in gLIMS.
Identify area end user requirements and enhancements to assist with Master Data Load in gLIMS.
Ensure the system master data is updated in a timely manner as required by the area.
Assist in validation (IQ, OQ, PQ) as required.
Author/review of validation protocols and reports to ensure compliance with current regulatory expectations.
Investigation of deviations and raising of change controls as required.
Minimum Qualifications and Experience:
Minimum of degree qualification in relevant science and/or IT discipline
3 years in a QA/QC/Validation/IT function with strong knowledge of CSV/GAMP, 21 CFR Part 11, Project Life Cycle and cGMP Regulations governing GxP data Direct experience maintaining master data in a cGMP environment is required.
Good working knowledge of laboratory testing processes and automation using various instrument software packages.