Job Summary:
We are seeking a highly skilled Microbiology Analyst to join our manufacturing 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
* Pursue Growth Promotion Testing and Culture Management
* Perform Microbial Limit Testing of Products and Active Ingredients (Non-Sterile - TAMC, TYMC, Absence of Specific Organisms) and support the Compressed Air Program
* Support Site Water Strategy
* Prepare and review Laboratory procedures, specifications, and reports
* Develop 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 in regulatory audits/visits (HPRA/FDA)
* Manage Laboratory Daily activities including Consumables/Media management, laboratory cleans, Equipment management, Temperature Monitoring, and Waste management
Desired Qualifications:
* Minimum Third level Qualification in Microbiology, Biological Science, or equivalent 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