Quality Assurance Employee

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, 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 inspections, preparing documentation and assisting QA personnel when required. Technical / Regulatory Skills Required:
• Basic knowledge of cGMP regulations
• Basic understanding of data integrity principles (ALCOA)
• Basic knowledge of pharmaceutical manufacturing processes
• Familiarity with GMP documentation systems Soft Skills Required:
• Attention to detail and accuracy
• Teamworking attitude
• Organizational skills
• Willingness to learn and develop GMP knowledge
• Reliability and accountability IT Skills Required:
• Basic knowledge of Microsoft Office tools (Word, Excel, PowerPoint)
• Familiarity with electronic document management systems (preferred)
• Basic knowledge of SCADA systems (preferred)
• Basic knowledge of SAP or similar ERP systems (preferred) Language Skills Required:
• Italian: Native or professional proficiency, written and spoken (C1)
• English: Professional proficiency, written and spoken (B2)

Education:
• Degree in Chemistry, Chemistry and Pharmaceutical Technology (CTF), Pharmacy, Biology or related scientific disciplines (preferred). or
• Diploma from an Industrial Technical Institute with specialization in Chemistry. Previous

Experience:
• Entry level or initial experience in the pharmaceutical sector.
• Internship or 0–2 years of experience in GMP environments (Quality Assurance, Production, QC or similar).