Role: Quality Assurance Employee

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Reports to: QA Manager
Main Responsibilities:

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- 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 documen

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