- 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
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 email@example.com
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