Job Title: Microbiology Analyst
We are seeking a highly skilled and experienced Microbiology Analyst to join our client's team in Cashel, Co Tipperary.
Job Duties:
* Lead the Environmental Monitoring Program and conduct associated risk assessments.
* Validate equipment and test methods for microbiological tests.
* Conduct 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.
* Participate 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).
* Manage Laboratory Daily activities including Consumables/Media and laboratory cleans, Equipment management, Temperature Monitoring, and Waste management.
Desired Qualifications:
* Minimum Third level Qualification in Microbiology, Biological Science, or equivalent.
* 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.