Microbiology Analyst

3 weeks ago


Nenagh, County Tipperary, Ireland Cpl Full time

On behalf of our Manufacturing Client in Cashel, Co Tipperary we are currently sourcing a Microbiology Analyst to join their Team.

Microbiology Analyst

Job Duties:


• Lead Environmental Monitoring Program and any associated risk assessments


• Complete validation of equipment and test methods for microbiological tests


• Growth Promotion Testing and Culture Management


• Microbial Limit Testing of Products and Active Ingredients (Non-Sterile - TAMC, TYMC, Absence of Specific Organisms). Support the Compressed Air Program.


• Support Site Water Strategy


• Prepare and review Laboratory procedures, specifications and reports


• Prepare and Execute protocols


• Involvement in Microbiological related investigations and Change Controls as required


• Support and participate in Technical audits as required


• Support preparation and participation of regulatory audits/visits (HPRA/FDA)


• Support Laboratory Daily activities including Management of Consumables/Media and laboratory cleans, Equipment management, Temperature Monitoring and Waste management

Desired Qualifications :


• Minimum Third level Qualification in Microbiology, Biological Science or equivalent is preferred


• Minimum 4 years' experience in a GMP Microbiology Laboratory


• Experience in Compendial Method verifications


• Technical understanding of Environmental Monitoring and Contamination control Strategy requirements (Annex 1)


• Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals.

This is a on site role Monday to Friday with flexible working hours. If you have the above skills & experience for this role, please contact or Tele:

#LI-CD1



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