International company based near Valls, Tarragona is searching for a Junior Quality Assurance Specialist.
Main functions:
1. Prepare all documents required for FDA activities, under the supervision of the Quality Assurance Manager.
2. Write, execute, and review all documentation related to the Quality system (including validation reports and protocols for C&S) and keep it updated.
3. Provide support and review documentation regarding qualification of equipment, measurement equipment, services, and systems.
4. Ensure GMP/FDA compliance and prepare necessary training.
5. Support audits of plant facilities by health authorities (FDA & AEMPS).
6. 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).
7. Review batch files and approve the release of FDA finished goods.
8. Prepare the Annual Product Review Report for FDA finished goods and conduct trend analysis reports.
9. Maintain the Quality System and train personnel on the Quality documentation system.
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