h3Role: Quality Assurance Employee /h3 h3Reports to: QA Manager /h3 h3Main Responsibilities: /h3 ul liSupports 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. /li liCollects and organizes supporting documentation related to change requests, complaints, supplier complaints, deviations, and CAPAs under the supervision of the QA Manager or QA Specialist. /li liSupports the monitoring of GMP compliance activities defined in approved documents, reporting potential discrepancies or delays to QA supervisors. /li liAssists 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. /li liSupports the drafting, formatting, and updating of Standard Operating Procedures (SOPs) and other quality documents. /li liSupports training compliance activities,



verifying training records and monitoring personnel qualification status. /li liPerforms preliminary verification of alarms and events recorded in SCADA systems in production and warehouse areas and reports relevant issues to QA supervisors. /li liSupports cleaning validation and cross-contamination prevention activities, ensuring documentation is properly collected and filed. /li liAssists in the preparation and maintenance of GMP compliance documentation, including quality plans, tracking lists, and documentation under QA responsibility. /li liSupports the preparation of Annual Product Quality Reviews (APQRs) by collecting and organizing the required data and documentation. /li liMonitors document expiration dates (SOPs, protocols, reports) and notifies responsible personnel to ensure timely revision. /li liEnsures correct document management in accordance with document control procedures and supports the archiving pro

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