GLP/GcLP auditor:

• Responsible for Quality Assurance in the Sanofi GCLP test facility at the Suzhou site

• Conducting internal audits (in-life, process-based and facility audits and audits of final reports)

• Conducting audits of electronic raw data

• Planning and documentation of audits and preparation of audit reports

• Collaboration in the further development of the audit program (study/process/facility-related audits)

• Supporting the GCLP test facility in publishing standard operating procedures in QualiPSO

• Perform GCLP training of employees

External audits:

• Conducting audits of external contractors in multinational teams

• Planning and documentation of audits and preparation of audit reports

• • Support of validations of computerized systems in GLP/GcLP areas as Business Quality Representative / Validation Expert for local and global computerized systems for GCLP relevant systems

Computerized Systems:

• Supporting R&D departments in implementing new computerized systems (local, on-premise or SaaS) and creating/implementing change controls for these systems

• Supporting R&D departments in conducting periodic reviews of computerized systems of the test facility

• Supporting R&D departments in implementing new digital workflows and electronic archiving of computerized systems

• Supporting the R&D quality system, e.g., by conducting internal and external GLP audits/inspections

Requirements & Qualifications

• Completed degree in natural sciences or scientific training with many years of experience in a GxP laboratory/area

• GxP knowledge and audit experience desirable

• Proficient use of MS Office programs and very good Mandarin and English skills (written and spoken)

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