LSC have an excellent opportunity for a QC Micro Analyst to join our team at our Athlone based biopharmaceutical client.
As QC Micro Analyst you will be responsible for:
o Environmental monitoring, water testing and all associated microbial testing as follows;
o Endotoxin testing, Bioburden testing, TOC/Conductivity testing, growth promotions, bacterial identification and Biological Indicator testing.
o Execution of tasks as part of Biologics start up for QC to include:
– Execution of URS in support purchase and qualification of QC lab equipment
– Drafting risk assessment to support sampling strategy of clean utilities and cleanrooms
– Drafting of test method qualification protocols
– Execution of testing to support biologics start up
o Accurate and timely recording of all information pertinent to the task being performed in the relevant Laboratory Worksheets / Notebooks and LIMS.
o Write and revise Procedures, deviations, CAPA, Change Controls and technical investigations and reports as assigned.
o Execution of validation protocols for process validation and method validation.
As QC Micro Analyst you will have:
o BSc. Degree in Science, Microbiology or related science.
o Minimum of 7 years of experience in cGMP Quality environment
o Experience in testing of sterile drug product and aseptic filling process of pharmaceutical /biopharmaceutical products.
o Experience in Method Validation
For full details on this role please contact Amparo in LSC on 021 4777329 or apply directly through this advert.