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Quality Specialist

  1. East
  1. Contract
Competitive
  1. Compliance / Quality Assurance
10-05-2023
31305
Quality Specialist - (Microbiology)- Life Sciences-Contract- Carlow

With worldwide demand for their life-changing oncology treatment increasing; one of our global pharmaceutical clients is looking for a Quality Specialist to join their team to support multiple capital projects taking place onsite in Leinster.

This is a fantastic opportunity to work on a state-of-the art fill-finish facility and the company’s first stand-alone vaccine and biologics plant outside the US.

Quality Specialist Responsibilities:
  • Development and execution of Microbiology test methods, Method Validation and Method Qualification, mainly bioburden, endotoxin, and Sterility test methods.
  • Troubleshooting of issues which arise during the execution of validation studies and routine tests.
  • Development of training modules.
  • Microbiology Support to Site Investigations
  • Driving Continuous Improvement initiatives, including lean lab initiatives, method optimization/redevelopment.
  • Authoring and managing change controls, procedures, test methods and deviations.
  • Result authorization for microbiological samples to support batch release.
  • LIMS System updates
About you:
  • Bachelor’s Degree or higher preferred; ideally in Microbiology or a closely related discipline.
  • Demonstrated change management skills (CEM) with continuous improvement.
  • Strong knowledge in execution, validation, and development of microbiology related test methods 
  • At least 5 years’ experience in the Microbiology Pharmaceutical industry or a similar operating environment.
Are you a good fit for a Quality Specialist? Get in touch with us today.

The candidate must have the rights to work in the location stated in the job advert.

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