Microbiological Quality Assurance Specialist

2 days ago


Dublin, Dublin City, Ireland Next Generation Full time

Next Generation is a leading pharmaceutical company based in Kildare, seeking an experienced Quality Control Microbiology Specialist to join our team.

About the Role

This exciting opportunity involves providing technical support to our QC Microbiology Laboratory and Operations. As a key member of our quality assurance team, you will ensure the continued manufacture and supply of high-quality pharmaceutical products. Your responsibilities will include method validation, equipment validation, troubleshooting, documentation development, and microbiological support across the site.

You will also play a crucial role in driving continuous improvement, training, and regulatory compliance within the microbiology function. This includes developing and executing microbiology test methods and project validations, troubleshooting issues during validation studies and routine microbiology testing, and authorizing microbiological test results to support batch release.

We are looking for a highly skilled professional with a Bachelor's degree or higher in Microbiology or a related discipline. You should have a minimum of 5 years of experience in a pharmaceutical microbiology environment, with strong knowledge and experience with microbiology test methods (e.g., Bioburden, Endotoxin, and Sterility testing).

As a successful candidate, you will demonstrate expertise in method validation and development, as well as experience in pharmaceutical regulatory compliance and change management. Excellent problem-solving, leadership, and communication skills are essential for this role.



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