A global pharmaceuticals R&D and manufacturing business based in Dublin are looking to hire a Qualified Person to support the batch release of products manufactured on-site and at a range of third-party locations.
The position will be responsible for the release of a complex portfolio of products whilst helping to support QMS implementation and taking the lead on site-wide quality improvement projects. The business is bringing in house biologics testing next year so you will be involved in QP support for this also as a key project.
Products are manufactured on-site as well as at CMO locations so you will get great exposure to multiple functions at a global business. You will be based on a well-established site so you will be well supported by a network of industry specialists in your role as QP.
As Qualified Person, you would have responsibility for:
- Inclusion on the Manufacturing License as a Qualified Person
- Product release: you will ensure that each batch is manufactured in accordance with the current EU/FDA GMP Directives and the relevant marketing authorisation.
- 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:
- Ideally looking for a candidate that has been on the Licence and released product however open to candidates with hands on batch release experience not as a QP.
- Ideally someone with manufacturing experience but this doesn't need to be in the QP role.
- 3rd Party Release/API Release will also be considered but will need to understand the finished Product Link.
- 3-5 years' experience is ideal. Will also consider less for candidates with the right attitude.
A salary of €75,000 - €85,000 is on offer dependent on the level of prior experience with an excellent benefits package including bonus, high annual leave and flexible working with the opportunity to work from home.
This position is a critical hire to support business growth so shortlisted will take place throughout December with interviews to be held early in January. 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.