Senior Microbiologist

Careerwise Recruitment

Clare

A Senior Microbiologist is required by CareerWise Recruitment for our Shannon based client. 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. 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: * 3rdl 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. Please call Tom Devaney today for further information on 091-758771 or email: tdevaney@careerwise.ie. CareerWise Recruitment (In Search of Excellence. CareerWise Recruitment specialises in the multinational sector in Ireland which predominantly encompasses the Medical Device, Sciences/Pharma and ICT industries. We also work into the Indigenous Engineering and Food Processing/Agri sectors. Established in 1999, CareerWise Recruitment is recognised by many of the major indigenous and multinationals companies to be one of Irelands leading specialist Technical and Executive Recruitment firms. We operate out of multiple locations in Ireland and have offices in Cork, Shannon, Galway and Dublin. Supporting Business Demands & Growth since 1999. 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. This job originally appeared on RecruitIreland.com.

2303 days ago