Quality Assurance Employee
Pubblicato il 07-09-2026 - ACS DOBFAR in Tribiano
Place of work:
Tribiano - Milano Sud
Job description:
Siamo alla ricerca di un/una 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 técnica e regolatoria.
Role: 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 procedures throughout the document lifecycle.
- Manage the Customer audit and assist management in regulatory inspection
Technical/Regulatory Skills Required:
- Basic knowledge of cGMP and data integrity regulations (ALCOA principles).
- Basic knowledge of main ma