- 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 firstname.lastname@example.org
Following your application for this specific role, Sigmar may contact you regarding other positions that we feel you may be suitable for. If you do not wish to be contacted about other opportunities please let us know. For further information please refer to the Privacy Statement on our website.