Description:
This is an exciting opportunity for a GRADUATE based in Dublin to join one of the fastest growing companies in a Quality Role and gain experience starting in their career.
Our client is a pharmaceutical company based in Dublin whose product portfolio covers a range of key therapy areas including atherosclerosis and cardiovascular disease, diabetes, infectious diseases, neuroscience and ophthalmology, respiratory, bone, arthritic conditions, and vaccines
Main responsibilities:
Quality Assurance
- Examine batch documentation and associated samples & thermologgers for products shipped to the UK. Under the supervision of the QA Associate release for distribution those batches already released for sale within the EU and submit the documentation to the QP for those imported from third countries when required
- Administer the change control and deviation procedures in the Quality system for supply chain quality issues.
- Record customer complaints and draft responses to complainants.
- General professional duties associated with maintaining the quality system
Regulatory Affairs
- Support in country submission management from planning to finalizing local submissions (incl. review & approval of dossiers, new documentation for label & artwork, when applicable)
- Support maintenance of archiving of printed promotional materials
- Support day to day regulatory operations
Ideal candidate will be/have:
- An Academic degree in Pharmacy, Chemistry, Life sciences, Pharmacology, Medicine or a related scientific discipline or other related field
- Background in Medicinal product distribution (desirable)
- Knowledge of Misuse of Drugs Act (UK) and of the application procedures for Domestic/import and export licenses.