Quality Assurance Employee

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78x49c

Role
Qualifiche, competenze e l'esperienza necessaria per questo ruolo sono disponibili nella descrizione completa riportata di seguito.

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 system in 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. xysqume

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 similar position within the sector

-

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

Seniority level

-

- Entry level

Employment type

-

- Full-time

Job function

-

- Production

Industries

-

- Pharmaceutical Manufacturing

#J-18808-Ljbffr

Vedi l’offerta su Go Lavoro: golavoro.it/annuncio-lavoro/78x49c