Qualified Person

  • Type: Permanent
  • Location: Limerick
  • Salary: Negotiable
  • Job Ref: QP090218
  • Date Posted February 9, 2018

Our client, a leading pharmaceutical company based in Limerick currently has an opportunity for a Qualified Person to join their expanding team. This is a full time, permanent position offering an excellent salary and benefits package.

Essential Duties and Responsibilities:

  • 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.

For more information on this position please call Melissa Foley on 05821665 or 061336136. Alternatively apply online and a member of the Harmonics team will be in touch

More Details

For more information on this position please call Melissa Foley on 05821665 or 061336136. Alternatively apply online and a member of the Harmonics team will be in touch

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