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Ruth Holland
Life Science

01 507 9255
[email protected]
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Details

Microbiology Manager


Reference:/RH/AQDG-418882 Location: Waterford
Qualification:DegreeExperience:7-9 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: BD Manager, Microbiologist, Microbiology Analyst, Microbiology Lab Supervisor

Life Science Recruitment are recruiting a permanent full time Microbiology Manager to join the team with our Pharmaceutical client based in Waterford.


The Position
The purpose of this position is to be the subject matter expert in our Microbiology function and lead a team of Microbiology team to manage and co-ordinate all activities in the Microbiology Laboratory including scheduling and people management

Responsibilities

  • Be the Site expert on microbiology; providing company-wide guidance and expertise
  • Introduce microbiological testing and provide support to the site including scheduling of all activities within Microbiology laboratory
  • Co-coordinating and managing Microbiology Analysts and supporting them in their role
  • Managing the Microbiology laboratory schedule to support operational activities
  • Performing support equipment URS, equipment implementation and laboratory set up
  • Ensuring that the existing laboratory tools are used to generate and maintain performance related metrics
  • Execution of routine utilities QC-Micro testing and environmental monitoring compliance with cGMP and Standard Operating Procedures
  • Overseeing the timely close out of deviations and/or investigations
  • Ensuring the timely completion of data reviewing as required
  • Identifying training requirements of Microbiology Analysts within laboratory and organize training as required
  • Drafting procedures and company documentation as required
  • Ensuring that all work carried out is in compliance with the required standards conforming to company, cGxP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
  • Ensuring microbiology laboratory personnel adhere to all good housekeeping practices
  • Identifying and making recommendations for improvements as part of a team within or outside the department in order to ensure continuous improvement.
  • Representing the Microbiology laboratory at various meetings
  • Governing Health & Safety protocols for the function:-
  • Ensuring requirements of site Safety Statement are implemented
  • Continuously promoting a positive safety culture by leading by example
  • Implementing safety requirements as per site documentation including SOP’s,
  • Safety Statement and COP’s
  • Report any defects
  • If unsure about safety requirements – ask
  • Ensuring the Microbiology laboratory adheres to highest standards of GLP including right first time
  • Managing all external laboratory testing, ensuring all testing is completed on time in
  • full
  • Recruiting, training, managing and developing team
  • Performing additional tasks as agreed to support effective running of the business

Qualifications and Skills Require


  • Qualified to a minimum of degree level in science discipline with a post-graduate qualification advantageous
  • At least 5 years’ experience in microbiology pharmaceutical laboratory and 3-4 years’ leadership experience
  • Previous experience in injection facility/sterile fills desirable
  • Good working knowledge of Regulatory Guidance for manufacture of sterile fill finish products
  • Supervisory management experience advantageous
  • Previous cross-functional project experience
  • GLP expert
  • Knowledge of GMP guides


For more information contact Ruth Holland on 087 7822198 or [email protected]