Senior QA Microbiologist

Job description

Senior QA Microbiologist

About Your New Employer

In your job as Senior QA Microbiologist, you will be working for a Galway based company that provides Medical Devices, Pharmaceuticals and Diagnostic products to help healthcare professionals

About Your New Job

  • You will ensure site compliance to the regulatory requirements of the In Vitro Diagnostic Regulation (IVDR) (EU) 2017/746.
  • It's your job to develop product knowledge, support product design and advise systems to ensure continuous improvement of processes
  • You will support preparation and participate in regulatory and customer audits and ensure the timely close out of NC actions / recommendations identified from associated audits
  • You will perform investigations into internal & external non-conformances using root cause analysis and develop corrective and preventive actions.
  • You will perform internal audits and report findings to the relevant area managers.
  • Provide technical support to Quality Control, Production Operations, and Customers when requested
  • Your job is to assist colleagues and personally develop all in-house documentation – including but not limited to Standard Operating Procedures, Validation and Performance Verification Protocols, Risk Assessments & records
  • You will report incidents, field safety notices and pharmacovigilance issues to head office quality department when required.
  • You will report on cGMP & health and safety compliance as well as ISO 9001 & ISO 17025 compliance

What You Need

  • A Degree in Engineering, Sciences or equivalent qualification.
  • Experience working in Microbiology 
  • Knowledge in the external regulatory requirements for IVDD 98/79/EC and IVDR (EU) 2017/746
  • Experience in cGMP, GDP and ISO environments

What's on Offer

In addition to all statutory entitlements and a meaningful job where you help save lives, you will get:

  • Option to work 1 day per week from home
  • Bonus
  • Career Progression Opportunities

What’s Next

Apply for your new job now by clicking the apply button, or contact Dean Flynn at Sigmar Recruitment for more information T: +353 91 455306 E:

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