Extensive experience in GXP auditing (GCP, CGLP, GMP), compliance and training. Actively participated in development & implementation of quality processes & procedures. Trained many professionals on ICH-GCP & various international regulatory requirements for clinical trials and clinical trial support service activities. At present, working as Manager Quality Assurance for various clinical trials which includes Investigator Site Audits, Data Management Audits, Pharmacovigilance Audits, System (process) and Vendor Audits . Also, look after process improvements and management of CAPA system.
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