Collins McNicholas

Senior Microbiology Manager

Our Client, a multinational healthcare company located in Mayo are currently looking for a Senior Manager Microbiology to join their team. You will be responsible for planning, supervision and control of a Microbiology Laboratory.

 

Responsibilities

  • Managing microbial testing of raw materials, in-process and final products.
  • Managing cleanroom and utilities microbial monitoring; ensuing cleanrooms operation as per design intent and utilities providing appropriate quality for product manufacture
  • Ensuring the laboratory is operated in a safe manner
  • Ensuing an effective quality management system is in place within the laboratory; ensuring appropriate root cause analysis is performed for any deviations and an appropriate investigation and impact assessment completed for any out of limits from within cleanrooms
  • Support ongoing initiatives within the laboratory.
  • Supporting and Coaching of Laboratory Supervisors and Technicians, providing motivation to the team and take appropriate corrective action on individual/team performance where required.
  • Ensuring SOPS are followed and comply with industry requirements and industry best practices
  • Ensure testing is completed in line with EP/USP and registered specifications
  • Ensure effective recording, analysis and reporting of Micro KPIs ensuring issues impacting quality performance are addressed.
  • Keeping up to date with industry best practices in terms of Microbiology testing and cleanroom monitoring
  • Supporting contamination control strategies for cleanroom operation
  • Perform assessments of personnel activities versus the SOP to ensure compliance
  • Involved in corporate and regulatory audits
  • Work closely with the production management team on site; providing assistance in investigation of contamination events and supporting batch assessment and CAPA

 

Qualifications

  • Scientific Microbiological Qualification
  • 5 years’ experience within Microbiology GMP environment
  • 2 years’ experience in a management role
  • Education and Experience
  • Scientific Graduate and/or Microbiology Laboratory & Cleanroom Technical knowledge
  • Strong background in Microbiology and Cleanroom operation
  • Extensive knowledge of microbiology tasks and associated regulatory standards and guidance.

 

For a confidential discussion and more information on the role, please contact Davin Ferguson on 0719140251 or email davin.ferguson@collinsmcnicholas.ie

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