Jian Li
Director, Audit Qa @AstraZeneca
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WORK HISTORY
Director, Audit Qa @AstraZeneca
Cambridge, GB
Actively lead or contribute to the strategic direction for a risk-based assurance programme. Designs, manages, and continuously improves an effective risk-based assurance programme for assigned GXP or regional area (i.e, APAC)• Leads, plans, and conducts the most complex audits in several GxP areas.• Leading and/or providing oversight to major regulatory inspections and provision of expert advice to Senior Managers on emerging regulatory issues• Managing business relationships with stakeholder groups and senior leaders, including management of significant CAPAs in collaboration with owning business functions• Acts as an expert in audit and GxP assurance and provides mentorship and coaching to audit staff• Conducts audits
EDUCATION
Capital University of Medical Sciences
master, Clinical Pharmacology
Jining Medical College
Bachelor, Clinical Medicine
ABOUT JIAN LI
A highly motivated medical doctor with strong work experience in Local Pharmacovigilance (PV) Operations became an auditor on 01Feb2012, responsible for the independent planning and conduct of audits of the Good Clinical Practice (GCP), PV and computerized system activities.Have done numberous audits, including Local Operating Company PV audits, Marketing Partner (mainly on PV) audit, Local Operating Company GCP audits, GCP/PV External Service Provider audits, and Clinical Investigator Site audit.Good quality sense and be able to apply risk based approach to audits and routine quality oversight.
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