The Quality Control system team will have responsibility to oversee all quality processes and digital solutions related to quality control management and to ensure compliance with the Sanofi global processes. The team also supports the delivery of ongoing QC continuous improvement initiatives.
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Overseeing all quality processes and digital solutions related to quality control management in compliance with the Sanofi global processes and quality control tools
Ensuring issuance and approval of all appropriate local quality control documentation, such as local procedures, templates… to support the QC processes and QC digital system usage, in the QC labs, in accordance with the Sanofi global processes.
Ensuring quality control processes supported by appropriate procedures are implemented locally and maintained, in line with Sanofi global and regulatory requirements.
Ensuring implementation and maintenance of QC digital solution (core model and local) (including data management and end-user management)
Ensuring archiving of all QC documentation, in compliance with the Sanofi global requirements and regulatory.
Ensuring training and support of end-users on QC processes and tools, in coordination with Sanofi global teams
Investigating on a timely manner and resolving any quality control events, issues or discrepancies from his/her perimeter. Implementing remediation actions from findings and CAPAs.
Providing support during regulatory inspections and audits by presenting QC processes and QC digital solution documents and records
Leading initiatives for continuous improvement in QC processes and tools usage, in coordination with QC excellence team.
Being representative of the site in the related CoPs led by the global, for the process in his/her scope, and if requested participating in the CoEs, and ensuring local communication.
Being representative of QC for the processes led by QMS team at site level
