The Microbiology Laboratory Manager is responsible for the establishment and ongoing management of a GMP-compliant microbiology laboratory in Ringaskiddy. The role ensures that laboratory systems, processes, and practices meet EU GMP, HPRA, FDA, and SGS quality requirements, while delivering reliable and compliant microbiological testing services to support client and business needs.
Key Responsibilities
- Lead the setup, implementation, and day-to-day operation of a GMP-compliant microbiology laboratory
- Develop, implement, and maintain the laboratory Quality Management System (QMS), including SOPs, test methods, policies, and controlled documentation
- Define and maintain microbiology standards to ensure compliance with EU GMP, FDA, HPRA, and SGS requirements
- Manage the installation, qualification (IQ/OQ/PQ), and lifecycle maintenance of microbiology laboratory equipment and systems
- Ensure laboratory audit readiness and support internal, client, and regulatory inspections, including CAPA management
- Oversee microbiological testing activities, including bioburden, sterility, endotoxin testing, microbial identification, environmental monitoring, and water testing
- Design, implement, and maintain environmental monitoring programmes, including sampling plans, trending, and reporting
- Implement effective microbial control and contamination control strategies
- Recruit, train, and manage laboratory personnel, ensuring training compliance, competency assessment, and performance management
- Ensure data integrity in line with ALCOA+ principles and electronic data system requirements
- Lead and support deviations, investigations, and non-conformances
- Collaborate with internal stakeholders including Operations, Quality Assurance, Training, and Business Development teams
- Ensure compliance with EHS, biosafety, and site safety requirements