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)