Seeking an experienced Qualified Person (QP) for a well-known pharmaceutical company based in Dublin to join their quality team.
This is a permanent role and an exciting opportunity to engage in a varied busy role within the company reporting to the Quality director.
The successful candidate will be QP Eligible and have minimum 2 years' experience named on an MIA license. Ideally, they will have experience with steriles and have hands on technical and on-site manufacturing experience. You will manage the QP release and certification activities for the EU and other markets and work in line with GMP guidelines. You must have a qualification in a relevant science discipline.
QP Release and certification activities of drug products (DP) for EU market.
Ensure drug product batch is manufactured and checked in line with MA and GMP guidelines.
Review product quality and quality systems for the DP.
Maintain QP register and QTA in line with DP activities.
Manage change controls on manufacturing site.
Review changes to equipment and documentation and approve.
Report any events to relevant health authorities in the EU market.
Support inspection and audit activities to ensure site is in line with regulatory authorities.
Investigate product complaints, recalls and deviations.
Act as a point of contact for different divisions within the business for GMP.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.