Microbiology Analyst

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 [email protected] or Tele: 087 2419644

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