On behalf of our Manufacturing Client in Cashel, Co Tipperary, we are currently sourcing a Microbiology Analyst to join their Team.
Job Duties:
1. Lead Environmental Monitoring Program and any associated risk assessments.
2. Complete validation of equipment and test methods for microbiological tests.
3. Growth Promotion Testing and Culture Management.
4. Microbial Limit Testing of Products and Active Ingredients (Non-Sterile - TAMC, TYMC, Absence of Specific Organisms). Support the Compressed Air Program.
5. Prepare and review Laboratory procedures, specifications, and reports.
6. Prepare and Execute protocols.
7. Involvement in Microbiological related investigations and Change Controls as required.
8. Support and participate in Technical audits as required.
9. Support preparation and participation of regulatory audits/visits (HPRA/FDA).
10. Support Laboratory Daily activities including Management of Consumables/Media and laboratory cleans, Equipment management, Temperature Monitoring, and Waste management.
Desired Qualifications:
1. Minimum Third level Qualification in Microbiology, Biological Science, or equivalent is preferred.
2. Minimum 4 years’ experience in a GMP Microbiology Laboratory.
3. Experience in Compendial Method verifications.
4. Technical understanding of Environmental Monitoring and Contamination control Strategy requirements (Annex 1).
5. Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals.
This is an on-site role Monday to Friday with flexible working hours. If you have the above skills & experience for this role, please contact us.
#J-18808-Ljbffr