Shaweta Sachdeva

WORK HISTORY

EDUCATION

ABOUT SHAWETA SACHDEVA

More than 13 years’ of quality assurance and overall 17 years of experience in the clinical research industry. Expert in conducting a variety of GCP audits (including for-cause/directed audits) in different countries for major pharma companies. Experience in preparing for and hosting regulatory inspections (USFDA, CFDA, TFDA) as well as conducting mock inspections for the sponsors and investigator sites. Also worked in the delivery of QA services to customers. Strong management and leadership skills with core competencies that include: Design/Re-design of the Quality Management System and its implementation Interpretation of regulatory requirements and consultation to operational staff Significant experience in management of global audits Investigation and management of quality issues Inspection preparation, coordination and follow-up Team development and training Development and implementation of quality culture programs International Audit ExperienceAustralia, China, South Korea, Taiwan, Singapore, Philippines, Malaysia, Thailand, Georgia, Austria Quality Systems Development and Audits Project Set-up and Project Execution Audits Investigator Site Audits Trial Master File Audits Vendor Audits (e.g. CRO, central laboratories, records management) Data Management Mock-Inspections (sponsor and investigator) Quality Issue investigation and management The audit activities typically include from planning, scheduling and conducting audits to reviewing and approving CAPA till closure of the audit. Experience on electronic audit management databases [Trackwise - Event Driven Analysis (EDA) and Veeva electronic Quality Management System (eQMS)].