Qualified Person

A leading biotech is looking to hire a Qualified Person who will help drive QA Operations and support the batch release process for the company's flagship biologics product.

The Qualified Person will help to establish and develop the QA team as the site progresses from clinical to commercial stage launch for biologics products manufactured on-site at their state-of-the-art facility in Dublin.

Within the role, you would be responsible for helping to develop the manufacturing quality release function, project managing key aspects of a bespoke QMS implementation, and driving the culture of the quality function and site. This is a key role for the group where you will be able to take the lead on setting and achieving key milestones in line with company strategy. You would be the lead named QP with the HPRA.

An excellent candidate for this role will have 3+ years of hands-on release experience in a sterile manufacturing environment with proven experience of driving a QA project through from start to finish.

As Qualified Person, you would have responsibility for:

  • Helping to establish, develop and grow quality assurance operations for commercial batch release.
  • Management and development of the Quality Assurance function - including future Qualified Person reports and additional QA staff
  • Leadership of bespoke and fit for purpose QMS implementation
  • Development of a new and complex batch release process specific for this product portfolio.
  • Support strategic oversight of the short, mid & long-term vision of the site
  • Qualified Person release of the biologics product portfolio in accordance with EU Directive 2001/83/EC.
  • QA oversight of manufacturing, testing and relating activities to ensure on-going cGMP compliance
  • Support site internal audit and participation in the preparation and hosting of external audits

You will have the following experience:

  • 3+ years of hands-on Qualified Person release experience in a sterile manufacturing environment.
  • Proven operational experience at driving through QA projects from start to finish.
  • Must meet the educational requirements of a Qualified Person as per EU Directive 2001/83/EC.

The salary on offer is €85,000 to €95,000 and can be higher for a candidate that brings very relevant experience. There is an excellent benefits package on offer also that includes, bonus, long-term incentives and more. Relocating candidates from the EU are also being considered providing you meet the requirements to act as a QP in Ireland.

Interviews are already taking place so if this looks like a great opportunity for you then please apply as soon as possible to be considered and ensure you do not miss out. You can also contact James Ivall at Goodman Masson should you want to discuss further.

Hope to hear from you soon.

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