The purpose of the role is to oversee the general running of the Microbiology laboratory, Environmental management and the aseptic technique associated with the manufacture of biologics products.
- Responsible for oversight of the Microbiology laboratory supporting the manufacture of Alofisel biologics product.
- Oversee aseptic practices (gowning, monitoring, cleaning and related training).
- The Senior Microbiology Analyst will perform microbiological testing and environmental monitoring as required to support operations.
- Ensure that the Microbiology laboratory is set up and operates in compliance with current
- Good Laboratory Practice / Good Manufacturing Practice at all times.
- Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations
- The Senior Microbiology Analyst will participate in the technical transfer / validation of microbiological testing procedures including Mycoplasma, Sterility testing and Endotoxin testing.
- Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP.
- 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.
The next Senior Microbiology Analyst should have a degree in Microbiology with more than 4 years experience working in the pharmaceutical industry. Experience with Endotoxin and Sterility testing is required, start-up experience would be preferable.
If you're looking for excellent career progression opportunities with one of the worlds largest Biopharma companies then send us your CV now. This role is based in a state of the art, first of its kind facility in Ireland.
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