Senior Qualified Person

2 weeks ago

Nenagh, County Tipperary, Ireland beBeeQualified Full time €75,000 - €90,000
Job Opportunity for Qualified Professional

We are recruiting for a qualified individual to join our organization in Tipperary.

Responsibilities:
  • The qualified professional will be involved in reviewing and certifying batches intended for use in clinical trials, ensuring compliance with EU Good Manufacturing Practice (GMP) and other regulatory requirements.
  • This role encompasses product manufactured across the organization's global supply chain and subsequently imported into the European Union, including small molecules, large molecules - biologics, vaccines, gene therapy, etc.
  • The qualified professional will work closely with health authority inspections to maintain site licenses and participate in internal and external audits.
  • Ongoing compliance activities related to clinical trials, such as technical and quality agreements with collaborators and stock recovery activities, will also be part of this role.
Requirements:
  • Eligibility to be named as a qualified person (QP) and maintenance of continuing professional development (CPD).
  • Practical experience with disposition of product types such as sterile, non-sterile, biologics, vaccine, gene therapy, or advanced therapy medicinal products (ATMP) is preferable.
  • At least two years' experience in quality assurance or qualitative analysis of related medicinal products.
  • Familiarity with EudraLex Chapter 4, Annex 13, Annex 16, and applicable EU clinical trial regulations (536/2014).
  • A recognized pharmacy degree course at a third-level institution in Ireland or equivalent qualifications from outside Ireland, along with registration with the Pharmaceutical Society of Ireland and acknowledgement from the EU competent authority where the pharmacy degree was completed.

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