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Details

Qualified Person (QP)


Reference:A005594 Location: Limerick
Qualification:DegreeExperience:2-3 Years
Job Type:PermanentSalary: Not Disclosed
May be suitable for: Qualified Person

Qualified Person (QP)
Our client, a biopharmaceutical organisation are currently recruiting for a Qualified Person (QP) to join their team on a permanent basis. The successful candidate will have experience working with biologics and will have been on a licence previously.

Responsibilities
• Manage the batch disposition process to ensure timely release of products
• Ensure 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

Requirements
• 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 further Information you can contact the recruiter directly:

Sinead Cullen | Tel: +353 (0) 1 507 9252