I am a QA professional with 14 years of work experience in GCLP (GLP, GCP).Experience in CSV activities with Veeva, MasteroControl, clinical trail software (Client Specifc).Hands on experience in QMS(Review of change control, deviation and CAPA) documents review in paper and electronically(Veeva eQMS).Experince on Vendor Audits. site quaification auditsParticipating regulatory inspections and sponsor auditsFaced different regulatory inspections i.e. USFDA, Turkey (MOH), ANVISA and regular DCGI inspections.Expertise in SOP preparation and review of QA, Clinical and Bioanalytical SOPs and enough knowledge on ICH-GCP, Schedule Y, USFDA and EMA.Audit experience in conducting Lab Audits(in-life), Internal and Process Audits, Vendor Audits.Extensive knowledge on review of computer system validation documentsLooking into the Document Archival Management