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Senior Microbiologist

Job description

Senior Microbiologist

JOB RESPONSIBILITIES:

  • Responsible for the oversight of the Microbiology laboratory supporting the biologics manufacture
  • Ensure that the Microbiology laboratory is set up and operates in compliance with cGMP
  • Oversee aseptic practices
  • Perform environmental monitoring as required and oversee environmental monitoring programme for the facility
  • Participate in the technical transfer / validation of microbiological testing procedures including mycoplasma, sterility testing, endotoxin
  • Training of new analysts and scheduling of work
  • Participate as required in global project teams relating to Microbiology and wider quality activities
  • Manage an effective laboratory documentation system. 
  • Prepare for, and support, internal and external audits (e.g. HPRA, FDA, corporate, customer)
  • Actively lead and support projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas
  • As required, act as designee for the Plant Microbiologist in their absence

JOB REQUIREMENTS:

  • Degree in Microbiology or other relevant field.

  • More than 4 years’ experience working in Microbiology in the pharmaceutical industry, preferably in a Biologics company

  • Extensive experience of microbiology testing - sterility, mycoplasma, endotoxin, environmental monitoring

  • Thorough knowledge of GMP and current FDA & EMEA regulations

  • Previous experience managing the performance of individual team members and the overall team

  • Knowledge and experience of Lean Laboratories is preferable

  • Previous experience in setting up a new Microbiology laboratory is desirable

If you would like to be a part of this exciting project and you meet the above criteria for the job, contact Clara on 01 4744676 or email your CV to chenry@sigmar.ie

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