This pharmaceutical organisation are a global player on the generics market, with around 15 molecules on the European and US market and a fully stocked pipeline of niche, complex and added value products. They also distribute a wide range of pharmaceutical products to pharmacies, wholesalers, hospitals and into various other healthcare settings globally.
They are currently looking for a talented Quality Assurance Officer to assist them to proactively manage the quality and compliance of their medicinal products.
Reporting into the QA Team Lead, some of the QA Officer duties will include:
- Help with due diligence and integration during new product developments / new product introductions.
- Agree Quality Agreements with external partners (contract manufacturers, logistic service providers, clients and distributors.
- Support technical product transfers, qualification and validation work and stability requirements.
- Investigate quality incidents, OOS, deviations and complaints, identify and follow-up CAPA's and supplier improvement plans together with contract manufacturers.
- Evaluate and follow-up Change Controls as per company procedure.
- Write Product Quality Reviews.
The successful candidate will have:
- An MSc in pharmaceutical sciences, industrial pharmacy, engineering, biochemistry, chemistry or equivalent through experience and a BSc.
- 2 years of relevant experience in QA in the pharmaceutical industry.
- Good knowledge of manufacturing processes for injectables and tablets.
- Knowledge of and experience in FDA regulations is an asset.
- Qualified Person certification is an asset.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.