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Qualified Person (QP)

Reference:SCAHSV-548065 Location: Limerick
Qualification:DegreeExperience:3-4 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person (QP)

Our client, a growing biopharmaceutical organisation are currently recruiting for a Qualified Person (QP) to join their organisation. As QP you will act in accordance with Annex 16, EudraLex, Volume 4 and directive 2001/83/EC to support disposition of products.


• 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


• 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