Biologics Quality Assurance Director

3 days ago


Carlow, Ireland Careerwise Recruitment Full time

At CareerWise Recruitment, we are seeking a highly skilled Biologics Quality Assurance Director to join our esteemed client's team. This pivotal role demands exceptional leadership and expertise in microbiological quality assurance.

The successful candidate will serve as the Subject Matter Expert (SME) on microbiological matters, providing guidance across departments. Ensuring compliance and operational excellence by sharing microbiological expertise and best practices is paramount.

The ideal candidate will lead microbial investigations, supporting root cause analysis (RCA) and corrective actions. Developing and maintaining critical microbiological documentation, including Cross Contamination Strategies and Impact Assessments, is also essential.

A strong background in microbiology, preferably in sterile manufacturing, is necessary for this position. In-depth knowledge of Eudralex Annex 1 requirements is also required.

This key role requires excellent analytical, problem-solving, and communication skills. Proven expertise in root cause analysis and risk management is essential.



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