03 set - Tribiano
Altro
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 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.
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
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