A medical device company located in Galway and Clare requires a Senior Microbiologist for a permanent job.
Key Duties and Responsibilities
- Responsibility for the implementation and maintenance of the microbiological programme including environmental monitoring programmes, (air, surface and particulate) and purified water process monitoring.
- Responsible for the validation of contract sterilisation for both Gamma Irradiation and EO sterilization as per ISO 11137-1, ISO 11137-2, ISO 11137-3, ISO 11135-1.
- Responsible for the maintenance of the quarterly Dose Audit programme for all sterilization families.
- Responsibility for implementing regulatory requirements in accordance with ISO13485, FDA QSR 21CFR Part 820.
- Involvement in Cleanroom validations, Water system validations and Cleaning validations.
- Preparation, execution and analysis of related Quality documentation.
Education, Experience and Skills
- Third level Qualification in Microbiology with at least 5 years' experience in a similar role
- A strong knowledge of water systems, Cleanrooms, biocompatibility and sterilisation is desirable.
- Thorough knowledge and experience of a regulated industry, including GMP, GDP, GLP.
- Knowledge of medical device quality standards/practices or similar regulated industry such as ISO10993, EN550, EN ISO 11135-1 and 11737-1.
For further information on this Microbiologist job or any other Micro jobs in Ireland please contact BImi Felix on 091730022 / email@example.com
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