She is a GCP compliance auditor with more than 17 years serving in Clinical Research CRO.

She oversee and deliver the execution of SYCON Quality Management System including internal project and system audits, Vendor Audits, Sponsor audit, regulatory inspections, software validation review and archive management in compliance with the ICH GCP E6(R2), Indian regulatory and application regulatory requirements.
She has experience of audit in various BA/BE studies of all type of formulations, Inhalation formulation, Phase I studies, complex and biosimilar studies. She has vast experience of various regulatory inspection like USFDA, MHRA, ANVISA, WHO, NPRA, MCC, AGES, CDSCO.

Prior to this, Pooja served as AGM Quality Assurance at Veeda CR with more than 5.5 years and as Assistant Manager Quality Assurance at SRSPL with more than 10 years. She hold a bachelor’s degree in Pharmacy from Shaurashtra University and certificate as a GCP trainer.