A global pharmaceutical company with a long standing history of developsing, manufacturing, marketing and distributing innovative and generic products is seeking to appoint a Quality Specialist to join their expert team at their affiliate South Dublin.
The Role:
Reporting to the Associate Director for Quality, you will be accountable for supporting Quality Systems and improvement projects cross functionally across the business on a global level. Your role will include:
- Performing batch reviews.
- Reviewing and approving GMP documents from contractors Supporting GMP/GDP training.
- Assessment and evaluation of complaints and deviations.
- In gap analysis and revisions to SOP's.
- Respond to and escalate non-conformance issues.
The Person:
You will possess the following:
- A third level degree in a science related field.
- 3+ years industry experience in Pharmaceutical/Medical device.
- Working knowledge of Quality GMP/GDP requirements.
- Working knowledge of the differences between EU, Global and US Marketing Authorisation Regulations.
- Eligible to live and work in EU.
To discover more about this opportunity apply now or contact Sorcha Hayward at HRM on 01- 6321866 for a confidential discussion.
