International company based near Valls, Tarragona is searching for a Junior Quality Assurance Specialist.
Main functions:
* Prepare all documents required for FDA activities, under the 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, measurement equipment, services, and systems.
* Ensure GMP/FDA compliance and prepare necessary training.
* Support audits of plant facilities by health authorities (FDA & AEMPS).
* Assist during investigations of Quality incidents and Out Of Specification (OOS) issues related to FDA finished goods, and follow up on Corrective & Preventive Actions (CAPA).
* Review batch files and approve the release of FDA finished goods.
* Prepare the Annual Product Review Report for FDA finished goods and conduct trend analysis reports.
* Maintain the Quality System and train personnel on the Quality documentation system.
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