A Permanent Microbiologist is required by CareerWise Recruitment for our Galway based Medical Devices client. Please contact Tom Devaney for more information. The client will only accept applications from candidates who are suitable and have permission to work within the E.U.

THE ROLE:
*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.

REQUIREMENTS:
*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

FULL JOB SPEC AVAILABLE FROM tdevaney (AT) careerwise.ie

CareerWise Recruitment accepts that you do not wish your CV to be forwarded to any client company without your prior consent and gives an absolute assurance that this wish will be respected at all times.

For further information please contact Tom Devaney @ 353-91-758771 or email tdevaney@careerwise.ie
Or apply on line on link below
CareerWise Recruitment
www.careerwise.ie
In Search of Excellence
Specialists in the recruitment of
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Supporting Business Demands & Growth since 1999