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Qualified Person (QP)

Job Seekers Ireland Engineering, Science Manufacturing, Pharmaceutical

Job Summary

  • Limerick
  • Permanent
  • BBBH770858
  • Nov 26, 2020
  • Competitive
Job Description

An industry leader is on the search for a highly qualified QP to join their business. Experience releasing products and being on a licence is essential

This opportunity is with a leading employer in the West of Ireland who are experiencing significant growth. They draw passionate, innovative and collaborative individuals to their business so if these are your key competencies then you will be in good company.

This is an excellent opportunity to join a high performing team that is leading the way in the Pharmaceutical/Biotech industry. To be considered for this role you will need a minimum 3 years of relevant work experience acting as Qualified Person and have been named on the licence.

Essential Duties

  • Manages the batch disposition process to ensure timely release of products
  • Ensures the batch disposition process maintains compliance with site practices & regulatory requirements
  • Disposition of products & materials in accordance with directive 2001/83/EC and Annex 16, EudraLex, Volume 4, EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use
  • Support major investigations, ensuring all product deviations are closed prior to batch release
  • Reviews and approves Product Quality Reviews
  • Reviews and approves new and revised master manufacturing records.
  • Participates in cross functional teams as Quality/Qualified Person representative
  • Participate in third party/supplier audits, as required
  • Provide additional QP support to quality related issues, as required

Education And Experience

  • Qualified Person status achieved with min 3 years of relevant work experience acting as Qualified Person, named on a Manufacturing and Importation Authorisation (MIA).
  • Biologics manufacturing experience desirable.
  • Aseptic / Sterile Drug Product manufacturing experience desirable.
  • Experience with IMP's (Investigational Medicinal Products) desirable.

If you would like to learn more about this opportunity contact Kellie on 021 2300 300 or kodonovan@morganmckinley.com or click the 'Apply now' button

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

kellie-o-donovan
Kellie O'Donovan
  • Senior Consultant | Engineering Recruitment - Quality & Validation
  • 353 (0) 21 2300300
  • kodonovan@morganmckinley.com