Quality Assurance Engineering

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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 process. /li liProvides support during customer audits and regulatory inspections, preparing documentation and assisting QA personnel when required. /li /ul h3Technical / Regulatory Skills Required: /h3 ul liBasic knowledge of cGMP regulations /li liBasic understanding of data integrity principles (ALCOA) /li liBasic knowledge of pharmaceutical manufacturing processes /li liFamiliarity with GMP documentation systems /li /ul h3Soft Skills Required: /h3 ul liAttention to detail and accuracy /li liTeamworking attitude /li liOrganizational skills /li liWillingness to learn and develop GMP knowledge /li liReliability and accountability /li /ul h3IT Skills Required: /h3 ul liBasic knowledge of Microsoft Office tools (Word, Excel, PowerPoint) /li liFamiliarity with electronic document management systems (preferred) /li liBasic knowledge of SCADA systems (preferred) /li liBasic knowledge of SAP or similar ERP systems (preferred) /li /ul h3Language Skills Required: /h3 ul liItalian: Native or professional proficiency, written and spoken (C1) /li liEnglish: Professional proficiency, written and spoken (B2) /li /ul h3Education: /h3 ul liDegree in Chemistry, Chemistry and Pharmaceutical Technology (CTF), Pharmacy, Biology or related scientific disciplines (preferred). /li /ul por /p ul liDiploma from an Industrial Technical Institute with specialization in Chemistry. /li /ul h3Previous

Experience:
/h3 ul liEntry level or initial experience in the pharmaceutical sector. /li liInternship or 0–2 years of experience in GMP environments (Quality Assurance, Production, QC or similar). /li /ul #J-18808-Ljbffr

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