Line Quality Assurance Employee

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gxd6r

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 partecipativo 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 documentation control pr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/7gxd6r