QC Micro Manager

PE Global; Cork; On-site; EUR 90,000 - 120,000; Full time

Job summary

PE Global is recruiting for a QC Microbiology Manager based in Cork for a contractor role. The incumbent will lead the QC Microbiology laboratory team, ensuring cGMP compliance and timely testing for drug substance and product, including environmental monitoring and sterility testing on site.

The role encompasses oversight of external testing labs, staff development, budgeting support, and collaboration with QA, Manufacturing, Regulatory Affairs and Supply Chain.

Qualifications

• Experience managing individuals and a team, including development and succession planning.
• Knowledge of lean laboratory principles and continuous improvement is preferable.

Responsibilities

• Lead the QC Microbiology team to operate in compliance with cGMP standards and meet testing timelines.
• Own environmental monitoring and utilities monitoring programmes with routine execution, review, reporting and trending.

Skills

Team leadership

Lean laboratory

5S

Operational excellence

Job description

PE Global is currently recruiting for a QC Micro Manager for a leading multi-national Pharma client based in Cork.

This is a contract position.

Role:

The QC Microbiology Manager reports to the Head of QC and is responsible for leading the QC Microbiology laboratory team at the client site. The team delivers the microbiological testing that underpins release and monitoring of drug substance and drug product, including anaerobic bioburden, environmental monitoring, water sampling, plate reading, growth promotion and associated trending and reporting.

Responsibilities:

• 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.
• Manage external microbial testing and relationships with external testing labs and suppliers.
• Develop the team in areas of technical expertise, use of operational excellence tools and high-performance team behaviours, including standard work, 5S and lean laboratory practices.
• Support laboratory equipment lifecycle, service programmes and new equipment introductions for the microbiology laboratory, and support method and equipment validation activities.
• Plan resource and capacity for the microbiology team against the manufacturing schedule, and manage stock of media, consumables and reference cultures.
• Maintain the laboratory in an inspection-ready state and represent QC Microbiology during regulatory inspections, customer audits and internal audits.
• Author, review and approve procedures, protocols, specifications, reports and change controls relating to microbiological testing and contamination control.
• Interface with other departments (Quality Assurance, Manufacturing, Facilities, Regulatory Affairs, Supply Chain) and with external contractors and contract laboratories as necessary.
• Participate as required in global project teams relating to QC Microbiology, contamination control strategy and wider quality activities.
• Support budget preparation and monitoring, including capital equipment needs, facility needs, staffing needs and contract service requirements.
• Identify and conduct personnel training for microbiology staff, prepare performance appraisals, and recruit and onboard team members.
• As required, act as designee for the Director, QC in their absence.

Requirements:

• 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.

***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***