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Microbiologist

Job Title: Microbiologist
Contract Type: Permanent
Location: Galway
Industry:
REF: 90521
Job Published: 7 months ago

Job Description

Contact: Bimi Felix
Email: bimi@hero.ie
Telephone: 0868395533

Microbiologist
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.


Key requirements:
  • 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.
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 further information on this Microbiologist role in Galway please contact Bimi Felix on 0868395533 / bimi@hero.ie
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