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