Quality Assurance Employee

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d0fn3

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

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/8d0fn3