International company based near Valls, Tarragona is searching for a Junior Quality Assurance Specialist.
Main functions:
* Prepare all documents required for the FDA activities, upon supervision of the Quality Assurance Manager.
* Write, execute and review all documentation related to the Quality system (including validation reports and protocols for C&S;) and keep it updated.
* Provide support and review documentation regarding qualification of equipment, measurements equipment, services and systems.
* Ensure GMP/FDA Compliance and prepare necessary training.
* Provide support to audits of Pla facilities by health authorities (FDA & AEMPS).
* Provide support during an investigation of Quality incident and out of spec (OOS) related to FDA finished goods, as well as, following of Corrective & Preventive Action (CAPA) defined.
* Review the batch file and release FDA finished goods.
* Prepare the Annual Product Review Report for FDA finished goods, as well as the trend analysis reports.
* Quality System maintenance and Train personnel on the Quality documentation system.
#J-18808-Ljbffr