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Vacancy Details

Science Pharmaceutical and Food

104482 - Senior Microbiology Manager - Mayo

Contract Type: Permanent
Location: Mayo
Date: 27/11/2019
Job Reference: 104482
Contact Name: Clara Burke
Contact Email:

Job Description

Senior Microbiology Manager - Mayo - 104482
Senior Microbiology Manager - Mayo

Our client, a pharmaceutical company in Mayo are currently looking to recruit a Senior Microbiology Manager for their site.

Job Summary
Responsible for planning, supervision and control of a Microbiology Laboratory by:
  • 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
  • Supporting and Coaching of Laboratory Supervisors and Technicians, providing motivation to the team and take appropriate corrective action on individual/team performance where required.
Supervisory Responsibility
  • 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
  • That the environmental monitoring and utility monitoring is supported with environmental monitoring risk assessments
  • Supporting contamination control strategies for cleanroom operation
  • Manage and contribute to the site quality goals as they relate to the Microbiology laboratory
  • Perform assessments of personnel activities versus the SOP to ensure compliance
  • An active member at presenting at quality management and trend meetings
  • Involved in corporate and regulatory audits; presenting the tasks of the Microbiology laboratory
  • Work closely with the production management team on site; providing assistance in investigation of contamination events and supporting batch assessment and CAPA.
Key Duties
  • Accountable for supporting Microbiology Laboratory Supervisors and Technicians
  • Accountable for Quality System within the laboratory; ensuring timely completion of reports and investigations and written to a high standard
  • Ensuring all testing is performed within defined timelines, is performed as per SOP and SOP is compliant with regulatory requirements
  • Ensuring effective monitoring and control of cleanrooms and utilities and contamination control strategies are supporting sterile manufacturing
  • Scientific Microbiological Qualification
  • 5 years’ experience within Microbiology GMP environment
  • 2 years’ experience in a management role
  • Strong background in Microbiology and Cleanroom operation
  • Extensive knowledge of microbiology tasks and associated regulatory standards and guidance.
  • Ability to anticipate, understand and address the changing regulatory environment of the industry.
  • Assess implications of new regulatory guidance and implement necessary changes as they relate
  • to Microbiology.

For further information on this Senior Microbiology Manager role in Mayo please contact Clara Burke on 086 8168273 /

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