Quality Assurance Employee

06 ott - Tribiano
ACS DOBFAR

ACS DOBFAR S.p.A., multinazionale italiana leader nella produzione di API e Prodotti Finiti, è alla ricerca di un Quality Assurance Employee da inserire nel dipartimento ufficio tecnico, con sede principale nel sito produttivo di Tribiano (MI).

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, rep

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