- The Senior Microbiologist will oversee the Microbiology laboratory supporting the manufacture of the biologics product as well as the aseptic practices within the laboratory.
- Perform microbiological testing and environmental monitoring as required to support operations.
- Ensure the Laboratory adheres to relevant GMP and GLP standards.
- Develop and maintain excellent communication and collaboration between the Microbiology laboratory and operations.
- The Senior Microbiologist will have to train and manage schedules of analaysts.
- Ensure that testing schedules are achieved and manage laboratory resources to provide a comprehensive analytical service for testing of all samples.
- Participate in the technical transfer as well as the validation of microbiological testing procedures such as 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.
- 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.
- Participate as required in global project teams relating to Microbiology and wider quality activities.
- The Senior Microbiologist witll have a BSc. in Microbiology (or other relevant field) and have 4 years experience working in pharmaceutical microbiology.
- Experience in a Biologics company is preferable.
- Experience of microbiology testing including Sterility, endotoxin, mycoplasma and Environmental Management
- Thorough knowledge of GMP and current FDA & EMEA regulations
- Strong Microbiology knowledge, with the ability to act as a Subject Matter Expert
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