Qualified Person

A global development and manufacturing biotech business based in Dublin are looking to hire a Qualified Person to drive the batch release process for a broad product portfolio across onsite manufacturing operations, external operations and at a network of CMO's.

Reporting into the Quality Director, this will be a senior role at one of the most highly regarded pharmaceuticals groups in Ireland with clear progression routes through the business. The role would suit you well if you are an ambitious QP looking to quickly grow your skillset, expand your network globally, and stamp your mark in an interested and varied role.

The position will support commercial operations and be responsible for the release of a broad portfolio of products as part of a highly skilled team. You will help to manage QMS implementation and take the lead on site-wide quality improvement projects. Products are manufactured on-site as well as at global locations so you will partner with multiple key stakeholders at a global business as a subject matter expert.

As Qualified Person, you would have responsibility for:

  • Product release: you will ensure that each batch is manufactured in accordance with the current EU/FDA GMP Directives and the relevant marketing authorisation.
  • Leading business critical quality projects
  • Supporting the implementation of the site excellence program by leading and implementing improvements
  • Quality performance reporting, and support of investigations.
  • Supporting the development of new quality system procedures and processes
  • Help drive Quality culture
  • GMP and GDP compliance

You will have the following experience:

  • Third level qualification in a science related discipline
  • Qualified Person status
  • Have supported quality/operational projects to drive business improvement
  • Hand on QMS experience and process improvement
  • Excellent interpersonal and communication skills
  • Experience of onsite pharmaceutical manufacturing

The salary on offer for this position will be €90,000. If a candidate has excellent relevant experience, then the salary can go higher. There is an excellent benefits package included also.

This position is an important hire to support business growth so candidate shortlisting will take place right away. If you are considering a move and this looks like it could right next step, then please apply as soon as possible to be considered for interview. You can also contact James Ivall at Goodman Masson to discuss further.

Hope to hear from you soon.

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