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 partecipativo 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.