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  • DUBLIN 2
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  • Job reference number:15276251
  • Client ID:RI/RD15912
  • Posted on:14-SEP-2017
  • Location:WATERFORD
  • Job type:PERMANENT

Senior Microbiologist - County Waterford

Job Purpose:
To be part of a new Microbiology function in a state of the art start up Fill Finish facility. Introducing methods, practices and procedures to both QC and production and ensuring aseptic and sterility assurances principle are implemented and maintained from project phase to routine operation.

Ensure all work is carried out in compliance with GMP, GLP and regulatory standards and guidance.
Ensure all work is documented in accordance with the highest GMP standards including maintenance of data integrity at all times.

Introduction and validation of all Microbiology methods in house including but not limited to Environmental Monitoring, Identifications, Growth Promotion, Sterility, Endotoxin (rapid method), Microbial Limit Testing, Biological Indicators
Reading of plates, data review, trending.
Assessment of trends and communication of findings to other departments.
Raising and Investigation of out of specification results.
Management of projects and testing contracted to external laboratories.
Performance of laboratory sampling and testing.

Provide technical knowledge and guidance on aseptic assurance, sterility assurance and trending as applicable to the production environment for the duration of the project and during routine operation
Participate in Operational Readiness for the duration of the project.
Participate in risk assessments as a Subject Matter Expert (SME).
Provide oversight during Media Fills.
Provide support during production investigations.
Provide support and back up to the Microbiology Manager and take on delegated tasks/projects as required.

Minimum Qualifications & Experience:
Demonstrated experience in providing Microbiological support to a production facility
Demonstrated ability to introduce, validate and optimise QC methods
Previous participation in regulatory audits an advantage.

Strong technical knowledge of Microbiology as it applies to both QC and Fill Finish facilities
Ability to implement cGMP and GLP
Thorough understanding of Method Validation as it applies to Microbiology

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