Job Description

Quality Management of third party manufacturers

• Perform GMP audits of third party manufacturers and CAPA (Corrective action and preventive action) follow-up.
• Complaints management. Review complaints investigation, CAPA plan and effectiveness review. Monitoring of complaints trend.
• Management and support product recall and return.
• Change control management. Review, perform impact assessment, risk assessment and coordinate change control process. Monitoring of change controls trend.
• Deviation management and out-of-specification investigation. Review major / critical deviations, OOS investigations, CAPA plan and effectiveness review. Monitoring of deviations / OOS / CAPAs trends.
• Participate in the evaluation, selection and approval of third party manufacturers
• Management of Quality Agreement with third party manufacturers. Setup / review / update of quality agreement.
• Management of Product Quality Reviews (PQR). Review of PQR, corrections/follow up action. Monitoring of PQRs trend.
• Review of technical reports e.g. stability reports, process /analytical validation reports etc.
• Quality Risk management in case of major / critical quality issue. Coordinate and participate quality risk meetings and prepare rapid quality notifications.
• Management of Quality and Safety Material Product (QSMP). Setup / coordinate / review / update of QSMP.
• Management of Quality Monitoring and Quality Review. Coordinate and participate in quality monitoring and quality review of third party manufacturers.
• Perform risk ranking of third party manufacturers.
• Manage termination of activity with third party manufacturers.

Quality Operations of EM CHC Asia Entity

• Support/perform management and continuous improvement of Quality Management System (QMS).
• Support/perform implementation of global quality standards and procedures.
• Support Quality Documentation System management, documentation Retention, Archival and Destruction.
• Support/perform Qualifications and Training of Quality/Regulatory personnel.
• Support/perform Self Inspection.
• Prepare and participate in EM CHC Asia Quality Review.
• Support/prepare Monthly Quality Reports for reporting to Global Quality.
• Collect and consolidate the quality KPI’s (Key Performance Indicators) of third party manufacturers for reporting to Global Quality.

Quality Support for Transversal Projects

• Provide Quality support for transversal project e.g. new product launch, site transfer or repatriation.

Others

• Any Ad Hoc activities as specified by the Reporting Manager

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.