Line Quality Assurance Employee

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Siamo alla ricerca di un/una Line Quality Assurance Employee motivato/a e attento/a ai dettagli, da inserire all’interno del team QA.

La risorsa, riportando al QA Manager, avrà un ruolo chiave nel garantire la conformità alle normative GMP, nella gestione delle attività di qualità e nella redazione e aggiornamento della documentazione tecnica e regolatoria.

Il/La candidato/a ideale possiede una solida base tecnico-scientifica, conoscenza dei principi di cGMP e data integrity, buone capacità analitiche e un approccio cooperativo orientato alla risoluzione dei problemi.

SOLAMENTE LE CANDIDATE/I DOMICILIATI ENTRO 30 KM DAL SITO DI TRIBIANO VERRANNO CONSIDERATI PER QUESTA SELEZIONE.

Role: Line Quality Assurance Employee
Reports to: QA Manager

Main responsibilities:
- Manages changes, complaints, deviations, and CAPAs through the electronic document management system.
- Collects and organizes supporting documentation for change requests, complaints, supplier complaints, deviations, and CAPAs.




- Monitors the progress of all GMP compliance activities defined in approved documents, reporting discrepancies to Supervisors.
- Drafts and maintains GMP documentation such as Risk Assessments, cleaning and cross-contamination reports, qualification protocols and reports for equipment, plants, and environments.
- Drafts and updates general and site-specific Standard Operating Procedures (SOPs).
- Verifies staff participation and supervises the qualification status of personnel.
- Verifies alarms on SCADA systemin production and warehouse areas, ensuring they are handled appropriately.
- Coordinates cleaning and cross-contamination activities in accordance with approved protocols and SOPs.
- Prepares and updates GMP compliance lists, plans, and documentation under QA responsibility.
- Drafts the Annual Product Quality Reviews (APQRs) and sends them to clients.
- Monitors document expiration dates (SOPs, protocols, etc.) and ensures timely revisions.
- Ensures compliance with

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7i13w9