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

📌 Quality Assurance Employee (Tribiano)
🏢 ACS DOBFAR
📍 Tribiano