Microbiology Manager

Microbiology Manager

Viatris

Inverin, Ireland

The Role & What You Will Be Doing

We are seeking a Microbiology Laboratory Manager will be lead and oversee the Viatris Galway Microbiology laboratory to ensure product safety and reliability, ensuring that all qualify and regulatory requirements are met.

Key expectations:

• Manage and control the microbial testing of pharmaceutical products for release;
• Ensure highest quality standards are maintained in areas of responsibility and that industry best practice is adopted in accordance with current GLP, GMP and regulatory body directives;
• Ensure all laboratory analysis is carried out in a safe, efficient and timely manner and ensure that systems and methods of analysis, sampling and testing are in place to allow for the generation of valid data;
• Ensure validity of all test methods in the laboratory are established and documented;
• Interact efficiently with other department managers/directors;
• Ensure department readiness for audits both internal and external authorities. Represent Quality management for Microbiology and interface with investigators during these inspections;
• Manage and support the Microbiology Team. Including establishing employee goals and objectives, assess performance, provide regular feedback, coach, develop and ensure dept. personnel are properly trained and remain in compliance with training requirements at all times;
• Support continuous improvement projects such as 6S and lean processes for the laboratory;
• Provide input to regulatory files in support of new product submissions and approvals;
• Maintain safety requirements.

Essential experience:

• Knowledge of working within an FDA/IMB regulated facility (preferably sterile injectables);
• Knowledge of Aseptic Processing;
• Knowledge of Monitoring and Management of the Microbial Environment;
• Project management, resource planning and budgeting;
• Working knowledge of isolator technology;
• Working knowledge of Environmental Monitoring of a Pharmaceutical Manufacturing Environment;
• Ability to work cross functionally with other departments (Analytical, Quality, Manufacturing and Regulatory).

Qualifications & Experience

• Minimum of Bachelor's degree in a Science related discipline (Microbiology/Pharmaceutical Sciences);
• 8 + years’ experience in experience within a microbiology/ quality department within a pharmaceutical company;
• Strong leadership experience is essential.