Director of Microbial Quality Assurance
7 days ago
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.
Your Role
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 Accountabilities
1. Subject Matter Expertise: Provide guidance and support on plant microbiological concerns, contributing to the development of technical documents and procedures.
2. Collaboration and Communication: Share your knowledge on microbiological procedures and best practices with various departments to ensure compliance and operational efficiency.
3. Investigation and Analysis: Participate in root cause analysis (RCA) teams to identify issues and develop preventive actions.
4. Technical Document Development: Assist in creating and updating microbiological technical documents, including Cross Contamination Strategies and Impact Assessments.
5. Risk Management: Perform quality risk assessments to evaluate microbial risks and collaborate on developing mitigation strategies.
6. Compliance and Governance: Ensure microbiological practices meet regulatory and internal compliance standards.
Your Qualifications
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.
What We Offer
As a valued member of our team, you will have opportunities for professional growth and development. If you have a strong passion for delivering high-quality products and a commitment to ensuring compliance, we encourage you to apply.
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