Qualified Pharmaceutical Specialist
We are seeking a qualified pharmaceutical specialist to join our team in Ireland. This is an exciting opportunity to work on a large-scale project with a global pharmaceutical client.
The successful candidate will be responsible for leading the drug product intermediate and final drug product quality release activities. They will ensure that batches have been manufactured and tested in accordance with current Good Manufacturing Practice (GMP) guidelines.
The ideal candidate will have achieved Qualified Person status and have relevant working experience as a Qualified Person named on a Manufacturing & Importation Authorisation (MIA). They will also have proven experience within the pharmaceutical industry in a QA/QC/Compliance role.
Responsibilities:
* Lead the drug product intermediate and final drug product quality release activities;
* Ensure that batches have been manufactured and tested in accordance with current GMP guidelines;
* Work with the specialist quality team to oversee quality management systems and quality processes;
Requirements:
* Qualified Person status achieved;
* Relevant working experience acting as Qualified Person named on a Manufacturing & Importation Authorisation (MIA);
* Proven experience within the pharmaceutical industry in a QA/QC/Compliance role;
* Excellent knowledge of regulations and sources of regulatory information;
* Knowledge of quality IT systems desirable (e.g. SAP, Trackwise, LIMS, QSAT);
* Degree or post-graduate qualification in Science, Pharmacy or equivalent.
This is a fantastic opportunity to be part of a fast-paced, cutting-edge project with lots of opportunities to learn and develop your skills. If you are a motivated and experienced pharmaceutical specialist looking for a new challenge, please apply now.