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Director of Microbiology Operations

1 week ago

Carlow, Ireland Msd Ireland Full time

At MSD Ireland, we are seeking a highly skilled and experienced professional to join our team as Director of Microbiology Operations. This role will be responsible for ensuring the highest standards of microbiological quality and compliance across our site.

We are looking for someone with a strong understanding of microbiological principles and practices, ideally in a sterile plant environment. The successful candidate will have expertise in Eudralex Annex 1 requirements and experience in technical appraisal, document review, and audits.

The Key Responsibilities of this role include:

  • Serving as the Subject Matter Expert (SME) for all plant microbiological concerns, providing guidance and support to various departments.
  • Sharing expertise on microbiological procedures and best practices to ensure compliance and operational efficiency.
  • Participating in microbial-related investigations, contributing to root cause analysis (RCA) teams to identify issues and develop preventive actions.
  • Assisting in creating and updating microbiological technical documents, including Cross Contamination Strategies and Impact Assessments.
  • Performing quality risk assessments to evaluate microbial risks and collaborating on developing mitigation strategies.
  • Supporting the inspection readiness program, ensuring microbiological practices meet regulatory and internal compliance standards.

To be successful in this role, you will need a Bachelor's degree in microbiology or a relevant discipline, along with relevant experience at this level in site microbiology or a related area. You should also possess excellent analytical and problem-solving skills, as well as strong written and verbal communication abilities.