Quality Assurance Employee

Siamo alla ricerca di un/una Quality Assurance Employee motivato/a e attento/a ai dettagli, da inserire all’interno del team QA. La risorsa, riportando al QA Manager, avrà un ruolo chiave nel garantire la conformità alle normative GMP, nella gestione delle attività di qualità e nella redazione e aggiornamento della documentazione tecnica e regolatoria. Il/La candidato/a ideale possiede una solida base tecnico-scientifica, conoscenza dei principi di cGMP e data integrity, buone capacità analitiche e un approccio collaborativo orientato alla risoluzione dei problemi.

Role: Quality Assurance Employee

Reports to: QA Manager

Main responsibilities:

• Manages changes, complaints, deviations, and CAPAs through the electronic document management system.
• Collects and organizes supporting documentation for change requests, complaints, supplier complaints, deviations, and CAPAs.
• Monitors the progress of all GMP compliance activities defined in approved documents, reporting discrepancies to Supervisors.
• Drafts and maintains GMP documentation such as Risk Assessments, cleaning and cross-contamination reports, qualification protocols and reports for equipment, plants, and environments.
• Drafts and updates general and site-specific Standard Operating Procedures (SOPs).
• Verifies staff participation and supervises the qualification status of personnel.
• Verifies alarms on SCADA systemin production and warehouse areas, ensuring they are handled appropriately.
• Coordinates cleaning and cross-contamination activities in accordance with approved protocols and SOPs.
• Prepares and updates GMP compliance lists, plans, and documentation under QA responsibility.
• Drafts the Annual Product Quality Reviews (APQRs) and sends them to clients.
• Monitors document expiration dates (SOPs, protocols, etc.) and ensures timely revisions.
• Ensures compliance with documentation control procedures throughout the document lifecycle.
• Manage the Customer audit and assist management in regulatory inspection

Technical/Regulatory Skills Required:

• Basic knowledge of cGMP and data integrity regulations (ALCOA principles).
• Basic knowledge of main manufacturing processes.

Soft Skills Required:

• Attention to detail and accuracy
• Teamworking attitude
• Problem-solving orientation
• Good analytical skills

IT Skills Required:

• Competency with Microsoft Office tools (Word, Excel, PowerPoint)
• Good knowledge of document and management systems (preferred)
• Good knowledge of SCADA systems (preferred)
• Basic knowledge of SAP system

Language Skills Required:

• Italian: Native or professional proficiency, written and spoken (C1).
• English: Professional proficiency, written and spoken (B2)

Education:

• Diploma of Industrial Technical Institute with specialization in Chemistry, or Degree in Chemistry or Chemistry and Pharmaceutical Technology (preferred)

Previous experience in the role or in a similar position within the sector:

• Minimum 1-2 years experience in a similar role within the pharmaceutical sector.