Cache of job #13856217

Employer

Collins Mcnicholas Recruitment

Job Title

Senior Microbiologist

Description

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. Principal Duties and Responsibilities. Responsibility for the implementation and maintenance of the microbiological program including environmental monitoring programs, (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 program for all sterilisation 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. This is not an exhaustive list of duties or functions. Qualifications/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. ******************************************************************************* For a confidential discussion and more information on the role, please contact Edyta Fleming on 091706721 or emailedyta.fleming@collinsmcnicholas.ie. For more information on our Recruitment and HR Services and to see a full list of our available jobs across Ireland, please visit our website www.collinsmcnicholas.ie. Follow us on LinkedIn and connect with our Recruitment Consultants to discuss the latest jobs as well as our job searching tips and videos! This job originally appeared on RecruitIreland.com.

Location

Galway

Date Added

206 days ago

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