QC Microbiology Manager

QC Microbiology Manager - Ireland, Cork - Initial 11-Month Contract - Life Sciences

What you'll deliver

• Lead the QC Microbiology team to operate in compliance with current cGMP standards at all times, ensuring samples are tested and results delivered within specified timelines.
• Own the site environmental monitoring and utilities (water and compressed gases) monitoring programmes, including routine execution, periodic review, quarterly reporting and trending.
• Provide oversight of out-of-specification, out-of-trend and excursion investigations, including microbial identification, root cause analysis and documentation of corrective actions.
• Own and provide oversight for sterility testing program on site related to the Drug Product Facility onsite.

Key requirements

• Understanding and familiarity with FDA and European regulatory requirements, guidelines and expectations for microbiological control, environmental monitoring and aseptic processing.
• Previous experience of managing the performance of individual team members and of the overall team, including development and succession planning.
• Knowledge and experience of lean laboratory principles and continuous improvement is preferable.
• Excellent written and verbal communication skills, with a customer focus and ownership of the speed, quality and accuracy of delivery.