About the Company
Our client is a globally recognised pharmaceutical company focused on delivering innovative healthcare solutions and maintaining the highest quality standards.
We are currently seeking a motivated Quality Control Specialist to join a high-performing QC Microbiology team within a regulated pharmaceutical manufacturing environment.
The successful candidate will support QC Microbiology operations, ensuring compliance with GMP, regulatory requirements, and company quality standards while driving continuous improvement initiatives.
Key Responsibilities
Support the Environmental Monitoring Program through data trending, analysis, and implementation of Corrective and Preventative Actions (CAPA).
Own and support Environmental Monitoring Risk Assessments and qualification activities.
Generate Quarterly and Annual Trend Reports for microbiology operations.
Develop and execute Microbiology Test Methods and Validation Studies.
Troubleshoot issues arising during Routine Testing and validation activities.
Provide microbiology support for Site Investigations, environmental monitoring, and utilities monitoring projects.
Drive Continuous Improvement initiatives including Lean Lab Projects and method optimization.
Author and manage SOPs, Change Controls, Deviations, and controlled documentation in line with GMP requirements.
Review and authorize microbiological results to support Batch Release activities.
Ensure compliance with Regulatory Requirements, ALCOA(+) Data Integrity Principles, and company Quality Standards.
Requirements
Bachelor’s Degree in Microbiology, Biology, Biotechnology, Pharmaceutical Science, or related Life Sciences field.
Minimum 3 Years’ Experience in a GMP QC Microbiology Laboratory.
Strong knowledge of Environmental Monitoring, Aseptic Processing, and Contamination Control.
Experience with Trending, Risk Assessments, Validation Studies, and Data Analysis.
Ability to author SOPs, Change Controls, Deviations, and quality documentation.
Familiarity with Regulatory Requirements, ALCOA(+) Data Integrity, and electronic laboratory systems.
Contract Details
This opportunity is an 11-month contract, on-site in Carlow.
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