M&S-GxP Auditor-Suzhou
Sanofi Group
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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