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:

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

Technical/Regulatory Skills Required:

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

Soft Skills Required:

1. Attention to detail and accuracy
2. Teamworking attitude
3. Problem-solving orientation
4. Good analytical skills

IT Skills Required:

1. Competency with Microsoft Office tools (Word, Excel, PowerPoint)
2. Good knowledge of document and management systems (preferred)
3. Good knowledge of SCADA systems (preferred)
4. Basic knowledge of SAP system

Language Skills Required:

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

Education:

1. 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:

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