We’re currently recruiting for an exciting opportunity with an award-winning Pharmaceutical organization based in Carlow. This is an excellent position for anyone who is looking to join a leading multinational who are one of the best at what they do.

The QC Associate Microbiology Specialist will provide technical support to the QC Microbiology Lab & operations to ensure the continued manufacture and supply of quality pharmaceutical products in meeting the priorities of: Compliance, Supply, Strategy and Profit Plan. This role holds more senior responsibilities within the Microbiology Laboratory including (but not limited to) documentation development, report writing, execution of method and equipment validation, drug product result authorization, providing microbiological support for site, performance of bench experiments as required.

.Duties:

• Development and execution of Microbiology test methods and project validations.
• Troubleshooting of issues which arise during the execution of validation studies and routine tests.
• Development of training modules.
• Microbiology Support to Site Investigations
• Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
• Authoring and managing change controls, procedures, test methods and deviations.
• Result authorization for microbiological samples to support batch release.
• LIMS System updates
• Assessing compendial and quality manual updates pertaining to the Microbiology Lab & environmental control.
• Supporting lab stock management and financial control as required.
• Supporting the environmental control program by trend analysis and implementation of appropriate corrective and preventative measures.
• Understands and applies regulatory / compliance and compendial requirements to their role together with remaining current on upcoming regulatory and compliance changes.
• Interprets customer needs, assesses requirements and identifies solutions to non-standard requests.
• Makes decisions within guidelines and policies which impact microbiology projects.
• Ensures highest safety standards.

• At least 5 years’ experience in the Microbiology Pharmaceutical industry or a similar operating environment.
• Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
• Demonstrated change management skills (CEM) with continuous improvement.
• Strong knowledge in execution, validation and development of microbiology related test methods i.e. Bioburden, Endotoxin and Sterility testing.