QC Microbiology Team Lead
RECRUITERS · Cork, County Cork, Ireland
Apply & track with Apply EdgeWe are seeking an experienced QC Microbiology Lead to lead the QC Microbiology laboratory team at a biopharmaceutical manufacturing site in Cork.Reporting to the Head of QC, you will provide both technical and people leadership, ensuring microbiological testing, environmental monitoring and contamination control activities are delivered in compliance with cGMP requirements and manufacturing schedules.Key ResponsibilitiesLead and develop the QC Microbiology team, ensuring compliant and timely testing.Own the site's Environmental Monitoring and Utilities Monitoring programmes, including water and compressed gases.Oversee OOS, OOT and microbiological excursion investigations, root cause analysis and CAPAs.Own and oversee the Sterility Testing Programme supporting Drug Product operations.Manage external microbiology laboratories, contractors and suppliers.Support method and equipment validation, equipment lifecycle activities and new equipment introduction.Drive Lean Laboratory, 5S and continuous improvement initiatives.Plan laboratory resources and capacity in line with manufacturing requirements.Maintain an inspection-ready laboratory and represent QC Microbiology during regulatory and customer audits.Author, review and approve relevant SOPs, protocols, reports and change controls.Collaborate with QA, Manufacturing, Facilities, Regulatory Affairs and Supply Chain.Support recruitment, training, performance management, budgeting and team development.Experience & SkillsStrong experience in pharmaceutical/biopharmaceutical microbiology and aseptic operations, with previous people management and team leadership experience.Good knowledge of cGMP, FDA and EU regulatory requirements, along with experience in environmental monitoring, sterility testing and microbiological investigations.Strong communication, organisational and planning skills are essential, while Lean Laboratory / continuous improvement experience is an advantage.If you would like to know more about this role, you can reach me at anamarija.bratovic@recruiters.ie You can also apply using the “Apply Now” button below.GDPR/Privacy Statement:By applying here you agree to RECRUITERS storing your CV in our secure applicant tracking system (ATS; Bullhorn). As your consultants, we are dedicated to helping you find a new job in your field of expertise and, equally, to keeping your personal information secure at all times. Your CV will not be sent to any third party without your consent. Your CV will not be sent to any third party without your consent.