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QC Microbiologist Analyst

QC Microbiologist Analyst (QCMicro-TUL-0601) Tullamore, Republic of Ireland

This role within the Quality Control group will support all microbiological testing carried out by the analytical group- utilities and method qualification and routine monitoring, In-process, Drug Substance and Drug Product testing, stability testing and raw material testing. The individual will also support the Zoetis Greenfield project with qualification of HVAC and clean utitlities.

Batch release responsibilities:

  • Testing of In-process, Drug Substance and Drug Product Batches manufactured
  • Validation of microbiological methods e.g. bioburden and endotoxin
  • Stability testing of Drug Substance and Drug Product Batches

Support of the microbiological requirements associated with a Greenfield project including product assessments and validation as required.

Support of HVAC and clean utilities:

  • Co-ordinating all site Utilities testing-environmental monitoring and water testing programmes.
  • Lead all environmental investigations, root cause analysis, and report close out.
  • Lead monthly environmental review meetings and present all relevant trends to a cross departmental team.

Support of the microbiological requirements associated with a Greenfield project including HVAC and clean utilities qualification projects.

General responsibilities:

  • Provide Microbiological support to the site
  • Provide annual contamination control training to all personnel. Provide aseptic technique training to all new employees.
  • Support autoclave validation programme.
  • Develop, maintain and update microbiological methods, specifications and SOP's in compliance with quality and regulatory requirements to allow the execution of the analysis in a GMP environment. This will include trending data, monitoring Out of Specifications and participating in laboratory investigations.
  • Participate in Quality and Safety regulatory audits.
  • Support raw material testing when required for GMP manufacture
  • Input into the identification of equipment requirements and work with vendors to ensure execution of all deliverables, including equipment qualification and validation.
  • Troubleshooting equipment and techniques within the Analytical team.

Participation in other projects/duties as defined by the QC management team.

Internal candidate Identified

 

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