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Director of Microbiological Quality

1 week ago

Portlaoise, Laois, Ireland Merck Gruppe - MSD Sharp & Dohme Full time

At Merck Gruppe - MSD Sharp & Dohme, we are seeking a highly skilled and experienced Associate Director, Site Microbiologist to join our team. As the Subject Matter Expert for all plant microbiological concerns, you will be responsible for providing guidance and support to various departments.

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Your core responsibilities will include:

  • 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

You will also be required to have:

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

We are looking for someone who is passionate about delivering life-changing medication to patients around the world. If you have the necessary skills and qualifications, please apply today.