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Site Microbiologist Leader

1 week ago

Dublin, Dublin City, Ireland Merck Gruppe - MSD Sharp & Dohme Full time
Company Overview
At Merck Gruppe - MSD Sharp & Dohme, we are dedicated to delivering life-changing medications to patients worldwide. Our state-of-the-art Carlow site is at the forefront of ensuring the highest standards of microbiological quality and compliance.

Job Summary
We are seeking a dynamic and committed Associate Director, Site Microbiologist to join our expanding team. As a key member of our site, you will be responsible for providing guidance and support on all plant microbiological concerns. Your expertise will ensure compliance and operational efficiency across various departments.

Key Responsibilities
1. Serve as Subject Matter Expert: Provide guidance and support on plant microbiological concerns, contributing to the development of technical documents and procedures.
2. Share Expertise: Share your knowledge on microbiological procedures and best practices to ensure compliance and operational efficiency.
3. Participate in Investigations: Contribute to root cause analysis (RCA) teams to identify issues and develop preventive actions.
4. Develop Technical Documents: Assist in creating and updating microbiological technical documents, including Cross Contamination Strategies and Impact Assessments.
5. Evaluate Risks: Perform quality risk assessments to evaluate microbial risks and collaborate on developing mitigation strategies.
6. Support Inspection Readiness: Ensure microbiological practices meet regulatory and internal compliance standards.

Requirements
1. Bachelor's degree in microbiology or a relevant discipline.
2. Relevant experience at this level in site microbiology or a related area.
3. Strong understanding of microbiological principles and practices, ideally in a sterile plant environment.
4. Expertise in Eudralex Annex 1 requirements.
5. Experience in technical appraisal, document review, and audits.
6. Excellent analytical and problem-solving skills.
7. Strong written and verbal communication abilities.
8. Proven experience in root cause analysis and risk management.

About You
You have a strong passion for delivering high-quality products and a commitment to ensuring compliance. If you have a bachelor's degree in microbiology or a relevant discipline and relevant experience in site microbiology, we encourage you to apply.