The position of Laboratory Quality Assurance Specialist will be located in our state-of-the-art bio facility in Dublin. The role is to support the Bulk Drug Facility with emphasis on microbiological testing, ensuring high standards of quality and compliance with regulations.
Main Responsibilities:
* Perform routine microbiological testing, including environmental monitoring, water sampling, bioburden analysis, endotoxin detection, TOC measurement, and method validation
* Maintain a high level of cGMP standards during testing and ensure laboratory housekeeping and safety standards are met
* Represent the Microbiology department in internal and external audits and investigations into out-of-specification results
* Review laboratory data, validation protocols, and reports for accuracy and adherence to regulatory requirements
Requirements:
* A minimum of 1 year's experience working in a cGMP quality environment
* Knowledge of current GMP regulations and industry standards related to sterile and non-sterile pharmaceutical/bio-pharmaceutical testing
* A degree in Microbiology or a related science field
Benefits of this role include:
* Opportunity to work in a cutting-edge laboratory environment
* Chance to develop expertise in microbiological testing and quality assurance
* Collaborative team environment with a focus on continuous improvement