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Qualified Person

  • Salary: Negotiable
  • Job type: Permanent
  • Location: Munster
  • Sector: Science
  • Date posted: 30/11/2018
  • Job reference: BBBH87186

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Qualified Person

My client, a leading biopharmaceutical organisation is currently seeking a Qualified Person to join their team. In this position you will be tasked to provide additional QP support to quality related issues, as required and reviews and approves new and revised master manufacturing records.

  • 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
  • Participates in cross functional teams as Quality/Qualified Person representative
  • Participate in third party/supplier audits, as required

Experience and Required Skills: 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.

For more information on this and other potential opportunities please contact Kathryn Whyte for a confidential discussion on 016455250