QA Officer

1. Qualification and Computerized system management

• Follow up Qualification & Validation Master Plan annually and manage performance accordingly
• Perform qualification, validation including: qualification of equipment (IQ/OQ/ Re-OQ/ CSV), Computerized system validation.

• Take responsibility of Administrator for assigned equipment /system.
• Manage GxP requirements related to CSV and data integrity (DI)

Utility aspect

• Monitor validations, issues related to environmental microbiology, utilities and facilites
• Monitor quality issues and follow up of maintaining GMP at Engineering department: review maintenance schedule, calibration schedule of equipments, utilities, check logbook, check calibration sheet
• Perform annual product quality review (PQR) for utility system (HVAC, purified water, compressed air), follow up CAPA implementation
• Take responsibility of Administrator for assigned equipment /system.

3. Quality System:

• Manage deviation and event system: monitor KPI Close investigation on time, close event, repeat & similar deviation. Take the Admin role of this system
• Carry out event investigation, follow up CAPA implementation and efficiency
• Carry out the assigned tasks according to GxP change control assessment
• Perform the gap analysis between Site's procedure, Global quality document, cooperate with other departments to implement appropriate CAPA
• Monitor the application and compliance between Site's procedure, Global quality document, requirements of Good Manufacturing Practice at Enginering department
• Participate in the Quality self-inspection, Global quality audit, regulatory inspection

Ensure that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.

• Compliance with HSE requirements
• Support other activities when needed

#LI-SEA
At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.