Description
QC gLIMS Administrator required by a leading biopharmaceutical organisation in Ireland to work on the global implementation of a new LIMs system. On an initial 6 month contract, this is a phased approach project, with basic functionally expected to be rolled out in Q4 2015.The QC gLIMS Administrator will be responsible for co-ordinating, 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 templates and specifications. This role will support QC and Manufacturing Operations.
- Administration and day to day support and training on gLIMS.
- Building, testing, verifying, transferring, reviewing and activation of all data required Master Data Load in gLIMS.
- Identify area end user requirements and enhancements following drafting and QC review of the Master Data Load in gLIMS.
- Be responsible for data loading for validation and ongoing operations for the applicable areas.
- Adhere to relevant documents, including SOP’s specifications and forms to ensure Master Data Load is completed using current documentation.
- Assist in the collection of the relevant documentation to support the MDL.
- Adhere to the appropriate levels of GMP when performing MDL.
- 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 reports to ensure compliance with current regulatory expectations, EU, FDA, and Corporate Standards and Internal Procedures.
- Investigation of deviations generated encountered during qualification/ Validation testing.
- Ensures that change requests and Document Change requests are compliant with all applicable procedures. This will involve reviewing SOP’s and the underlying documents for compliance.
- Generate SOP’s/ other documentation as applicable.
- Assist in additional duties as directed by QC Lab Support Manager.