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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