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 Team Lead to proactively manage the quality and compliance of their medicinal products.
Reporting into the company Group QA Director, the QA Generics Team Lead will be the QA representative for the Generics business, manage the team and be responsible for all quality aspects within the business.
- 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.
- Identify gaps and areas for improvement in QA processes and handling and lead remedial actions and initiatives.
The successful candidate will have:
- An MSc in pharmaceutical sciences, industrial pharmacy, engineering, biochemistry, chemistry or equivalent through experience and a BSc.
- 6 years of relevant experience in QA in the pharmaceutical industry.
- Good knowledge of manufacturing processes for injectables and tablets.
- Be able to manage internal- and external project teams in person and remotely.
To discover more about this opportunity, apply now or contact Helena Boyle at HRM on +353 1 6321870 or 0873360953 for a confidential discussion.