Are you passionate about ensuring the highest standards of microbiological quality in a world-class biologics environment?
The Role:
* Serve as the Subject Matter Expert (SME) on microbiological matters, providing guidance across departments.
* Ensure compliance and operational excellence by sharing microbiological expertise and best practices.
* Lead microbial investigations, supporting root cause analysis (RCA) and corrective actions.
* Develop and maintain critical microbiological documentation, including Cross Contamination Strategies and Impact Assessments.
* Conduct quality risk assessments, identifying microbial risks and driving mitigation strategies.
* Strengthen inspection readiness, ensuring full compliance with regulatory and internal standards.
Requirements:
* Bachelor's degree in Microbiology or related field.
* Leadership experience in site microbiology.
* In-depth microbiological knowledge, preferably in sterile manufacturing.
* Expertise in Eudralex Annex 1 requirements.
* Strong experience in technical appraisals, document reviews, and audits.
* Excellent analytical, problem-solving, and communication skills.
* Proven expertise in root cause analysis and risk management.