Micro Scientist

CPL

Limerick

The Micro Scientist responsible for carrying out tasks and projects related to equipment, lab utilities and testing procedures for the Facility project as required by Good Manufacturing Practice (GMP. Partners with other Departments to ensure that all QC testing activities are completed in an efficient manner. Performs Microbiological and/or Chemical testing activities in relation to method validation and technical transfer activities so as to ensure that all methods meet ICH, CFR and USP guidelines. Executes testing activities as specified in IQ/OQ and PQ protocols so as to ensure that all relevant equipment is qualified for cGMP use. Performs routine Microbiological and/or Chemical testing activities during Plant production phase. Reviews laboratory test results when required. Ensures that testing and results approval are completed within agreed turnaround times. Writes and reviews laboratory SOPas as directed by company policy. Ensures QC activities are carried out in compliance with product licence commitments, cGMP and company quality standards. Is an active member of the QC group and provide assistance with other group activities as required and communicates relevant issues to the QC Team Leader. Anticipates and plans for future requirements in the area.

1150 days ago