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Principal Auditor - Quality

Job Seekers Ireland Science Pharmaceutical

Job Summary

  • Dublin
  • Permanent
  • BBBH788923
  • Jul 29, 2021
  • Competitive
Job Description

I am currently seeking a principal auditor to join a growing quality team in the pharmaceutical sector on a permanent basis.

This person will independently organise and perform quality audits including supplier, corporate and third-party audits. This role is a mixture of remote and on-site work and will also require travel to sites in the US predominantly

Requirements:

  • Degree in Science, engineering, technical or relevant discipline essential.
  • 8 years' experience in working in pharmaceutical manufacturing or a QA or compliance environment.
  • Experience in API, Medical device, Sterile, injectables or combined device products desirable.
  • Experience in supplier and corporate auditing essential.
  • Excellent knowledge of domestic and international regulations such as GMP, GLP and ICH guidelines related to pharmaceutical dosage devices.
  • Extensive experience in audit areas such as API, Micro Lab, sterile drug product and Mock PAI.
  • Ability to conduct audits independently of drug product or medical device.
  • Must have flexibility to travel internationally when needed.

Responsibilities:

  • Management of the auditing program including tracking audit responses and auditees CAPA completion and close out.
  • Complete multiple supplier audits throughout the year and lead corporate audits for the company.
  • Evaluation of quality systems and practices.
  • Support the audit program by conducting internal and external audits by leading or supporting audit team.
  • Organize and lead periodic audit review meetings.
  • Partake in and support FDA inspections in line with regulatory authorities during inspections.

For more information on this role and a confidential discussion please contact Aoife O'Driscoll, QA, and Validation Specialist Recruitment Consultant @ Morgan McKinley 021 2300 300 / aodriscoll@morganmckinley.com

Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.

BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR TERMS OF SERVICE WHICH TOGETHER WITH OUR PRIVACY STATEMENT GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

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Consultant Details

Consultant Details

Aoife O'Driscoll
Aoife O'Driscoll
  • Consultant
  • +353 (0) 21 2300300
  • aodriscoll@morganmckinley.com