Cork: +353 21 4509200 | Dublin: +353 1 5175910
jobs my account call discover now > discover now >
Search Jobs

Qualified Person

Quality & Laboratory
Claire Goulding
Favourites Share with a friend
Job Reference: JO-2305-66432_1683210217


Our client has an exciting opportunity for a Qualified Person to join the team in a large biopharmaceutical company. If you are someone who wants to be part of an organisation that brings life-changing medicines to those who need them, this could be the career step for you!


  • The Qualified Person (QP) is responsible for fulfilling QP responsibilities in relation to batch release of commercial and clinical product, in accordance with the requirements of 2001/83/EC, 2001/20/EC, Annex 16 and Annex 13 requirements as applicable.
  • The QP ensures all products certified have been manufactured in accordance with the requirements of its marketing authorisation/ CTA and are in compliance with cGMP requirements.
  • Provide technical expertise for all QA and compliance topics /issues relating to manufacturing and product supply of drug products and finished goods.
  • Routinely monitoring the company's operations to ensure compliance with site licenses and Good Manufacturing Practices bringing any critical and major deficiencies to the attention of the Head of Quality Assurance.
  • Participate in management reviews of process performance, product quality and of the quality management system in order to identify and action opportunities for continual improvement.
  • Participates in cross-functional teams as the Quality/Qualified Person representative.
  • Reviews and approves Product Quality Reviews.


  • QP Qualification with at least 8 years of Quality experience in an EU-licensed facility in a relevant functional area.
  • Qualified Person status achieved with min 3-5 years of relevant work experience acting as Qualified Person named on a Manufacturing and Importation Authorisation (MIA/ IMP MIA).
  • Aseptic / Sterile Drug Product manufacturing experience desirable.
  • Experience with IMP's (Investigational Medicinal Products) desirable.
  • Experience with participation in regulatory inspections, presenting or defending departmental functions in audits or regulatory inspections.
  • Understanding and familiarity with European/ FDA regulatory requirements, guidelines, and expectations.
  • Ability to comprehend technical information related to equipment, processes, and regulatory expectations.
  • Maintain knowledge up to date with respect to the current Good Manufacturing Practices (cGMP), technologies and quality systems for the products they certify.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists

View more Jobs in Quality & Laboratory
Share this job with a friend:
Ask a question about this job
More jobs from Claire Goulding >
View more Jobs in Quality & Laboratory
Share this job with a friend:
Website Design by Dmac Media