|Job Published:||about 2 years ago|
Our client, a medical device manufacturing company located in Galway require an experienced Microbiologist. This is a permanent role in Galway
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.
? The microbiologist will have to 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 3 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
For further information on this Microbiologist role in Galway please contact Cliona O?Malley on 091730022 / email@example.com
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