Microbiology professional with a strong focus on quality assurance and regulatory compliance. Proven leadership in managing laboratory operations and driving continuous improvement initiatives, ensuring adherence to GMP and GLP standards while fostering team performance and optimizing processes.
Overview
10
10
years of professional experience
Work history
Senior Microbiology Team Lead
Viatris
Galway, County Galway
2025.06 - Current
Oversaw day-to-day operations, ensuring adherence to company standards.
Liaised with senior management on strategic planning initiatives, contributing valuable insights.
Facilitated open dialogue with stakeholders to manage expectations effectively.
Lead microbiology investigations including environmental monitoring, sterility failures, bioburden, endotoxin, and contamination events.
Drive root cause analysis, risk assessments, CAPAs, and effectiveness checks for microbiological deviations and quality issues.
Ensure compliance with GMP, GLP, Data Integrity, and regulatory standards across all laboratory activities.
Oversee validation and lifecycle management of microbiological methods, equipment qualification (IQ/OQ/PQ), and method transfers.
Review and approve microbiology documentation, including test results, environmental monitoring data, and investigation reports.
Support and continuously improve the Environmental Monitoring (EM) program for manufacturing and aseptic areas.
Lead and maintain microbiology quality systems, including SOPs, change controls, deviations, and trend reporting.
Provide technical leadership, mentoring, and training to microbiology team members.
Manage laboratory operations, including resource planning and prioritisation, to meet business needs.
Support audits and inspections, representing the microbiology function and ensuring timely follow-up actions.
Drive continuous improvement initiatives and operational excellence within the laboratory.
Act as deputy to the Microbiology Laboratory Manager when required.
QA/QC Microbiology lead
Vantive Healthcare Pharmaceutical
2024.08 - 2025.05
Supervise and manage a team of microbiologists in microbiology Department.
Coordinate daily operations and ensure that objectives are set, supervised, and completed in proper priority.
Responsible for the monitoring of starting materials, finished and environmental control systems and routine testing where required.
Generation of documented procedures for microbiological monitoring and responsible for compliance with documented procedures.
responsible for identification and communication of trends in routine microbiological monitoring
Coordinate sterilization testing and testing to support manufacturing and new product development.
Improved product quality by implementing rigorous QC testing procedures for microbiological analysis.
Manage SOP updating to ensure compliance with regulatory requirements.
Ensured regulatory compliance with FDA, EU and ISO guidelines through strict adherence to protocols and proper documentation.
Collaborated with cross-functional teams to address product quality issues related to microbiology.
QC Micro Analyst
Wuxi Biologics
2022.06 - 2024.07
Perform routine testing, environmental monitoring, water monitoring, and testing including sterility, endotoxin, bioburden, biological indicators, growth promotion , sterility, and routine microbiological indicators.
Support in OOS,OOL, Microbial contamination, adverse trends, environmental excursion investigation, change controls, Deviation, CAPAs Task.
Author and review technical documents including methods protocols, Logbooks, controlled documents, reports and SOPs.
conduct routine inspection of Lab to ensure compliance with cGMP, GDP and GLP.
Provide effective communication and play a leading role in project management interaction with external and internal audits clients.
perform all duties in compliance with GMP Requirements, SOPs and controlled documents.
Act as site subject matter for Nitrate testing.
Maintained and calibrate all laboratory equipments in the laboratory.
QC Analyst
Regeneron Pharmaceutical Ireland
2021.05 - 2022.05
Conducted regular inspections of incoming materials, components, and finished products.
Performed accurate and timely data entry for QC records.
Ensured that all work is performed within the framework of Good Manufacturing Practices.
Trained new personnel on QC procedures, including sampling techniques and data interpretation.
Monitored and supervised routine KPI Laboratory stocks, reagents and consumables.
Senior Team Lead – Learning and Performance at Canadian Air Transport Security AuthoritySenior Team Lead – Learning and Performance at Canadian Air Transport Security Authority