Our client, a medical device company in Galway are currently looking to recruit a Microbiologist for their site.
This position exists as a QA function with its primary purpose to assure sterility of product released into commerce and assures analytical testing of various materials. This is accomplished through a wide variety of duties which support the routine operation of the Microbiology and Analytical Laboratory.
- 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.
- Support the internal audit program.
- Involvement and general support to the Quality group including execution of assigned projects.
- Third level Qualification in Microbiology with at least 5 years' experience in a similar role (relevant experience in same with equivalent third level Science Qualification will be considered)
- 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.
- Knowledge of regulatory requirements
- Good knowledge of CAPA, NCR and deviation process
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