ARPITA TRIVEDI

Skills

Quality Management Systems (QMS), Pharmaceutical Compliance, Regulatory Inspection Readiness & Audit Defence, Internal Audit & Compliance, OOS / OOT & Laboratory Incident Investigation, Deviation Management, CAPA, Change Management, Risk Assessment, Stability & Retain Sample Management, Batch Record Review & Release, GMP Document Control (SOPs, STPs, Specifications, VMP), Analytical Method Validation

About

defending laboratory data before USFDA, UK MHRA, KDMF, WHO, TGA and PMDA authorities, along with ANVISA consultant audits. Strong background Pharmaceutical Quality Assurance and Quality Control professional with 18+ years of experience across API, sterile (lyophilised SVP), oral liquid, ointment and Ayurvedic manufacturing environments. Currently serving as Deputy Manager at Zydus Lifesciences Limited, with expertise in QC management, stability review, batch release, quality agreements, training programmes, product inspection and regulatory compliance. Proven experience in hosting regulatory inspections and in OOS/OOT investigations, deviation and CAPA management, change control, data integrity (21 CFR Part 11 and ALCOA+), and establishing QC functions for greenfield projects. Holds an MBA in Pharmaceutical Management and an MSc in Chemistry, both with Distinction, and has completed Six Sigma Black Belt training.