Role: Quality Assurance Employee
Reports to: QA Manager
Main Responsibilities:
Supports the management of GMP quality events, including changes, complaints, deviations, and CAPAs through the electronic document management system, ensuring correct data entry and document collection.
Collects and organizes supporting documentation related to change requests, complaints, supplier complaints, deviations, and CAPAs under the supervision of the QA Manager or QA Specialist.
Supports the monitoring of GMP compliance activities defined in approved documents, reporting potential discrepancies or delays to QA supervisors.
Assists in the preparation and maintenance of GMP documentation, including Risk Assessments, cleaning validation reports, cross-contamination reports, and qualification protocols and reports for equipment, facilities, and environments.
Supports the drafting, formatting, and updating of Standard Operating Procedures (SOPs) and other quality documents.
Supports training compliance activities, verifying training records and monitoring personnel qualification status.




Performs preliminary verification of alarms and events recorded in SCADA systems in production and warehouse areas and reports relevant issues to QA supervisors.
Supports cleaning validation and cross-contamination prevention activities, ensuring documentation is properly collected and filed.
Assists in the preparation and maintenance of GMP compliance documentation, including quality plans, tracking lists, and documentation under QA responsibility.
Supports the preparation of Annual Product Quality Reviews (APQRs) by collecting and organizing the required data and documentation.
Monitors document expiration dates (SOPs, protocols, reports) and notifies responsible personnel to ensure timely revision.
Ensures correct document management in accordance with document control procedures and supports the archiving process.
Provides support during customer audits and regulatory inspections, preparing docum

📌 Quality Assurance Employee (Italia)
🏢 ACS DOBFAR
📍 Italia