Les offres d'emploi : Professions sociales - Santé ...

As the Quality Engineer you will be responsible for ongoing quality management of the portfolio of highly regulated products. This will entail the following responsibilities:
-maintain the status of the assigned European market portfolio
-initial and ongoing quality audits and technical support
-quality issues management (i.e. holds, phase I, rejects, etc.)
-micro and analytical laboratory qualifications
-complaint management
-CAPA management, deviation process
-quality agreement, change control
-recall due diligence, leading on-site investigation process
-NPI, registration, product dossier review, quality clearance, FAI
-quality follow-up of newly launched products

- Master degree + Qualified Person qualification
- plant experience in QA function, laboratory or Operations or regulatory affairs
- solid knowledge of the European GMP for APIs and medicinal products as well as understanding of FDA requirements
-solid knowledge of sterile product manufacturing and applicable requirements
- At lest 2 years experience in a pharmaceutical manufacturer
-previous job experience in a governmental agency or proven track of ongoing...