I am a detail oriented, visionary leader and task master with 23+ years of versatile & fulfilling experience with challenging roles in multiple functions (QA, CQA, Manufacturing, QC and Microbiology). An adept learner, risk taker & lean champion, focused on continual improvement, fascinated by complexities to simplify & resolve them through scientific rationale and risk-based approach for compliance & decision making.An assertive leader, accomplished successes in complex tasks with ease through collaborative style of working and ensuring that organizations move to system-based functioning instead of individual led working thus achieving sustainable change and accountability at each level.Core strengths in designing, implementing and management of world-class Quality Management System (QA, Audit & compliance) aligned to the expectations of all the leading Global Regulatory Agencies i.e. US FDA, EMEA, WHO-Geneva, Health Canada, MHRA and MCC.Experience and expertise in Successful Quality Integration and GMP remediation for USFDA.Adroit management of HA Inspections, Internal Quality Audits, Regulatory Response Writing, Quality Risk Management Program, extensive expertise in writing of technical GMP documents, Product Quality Reviews, Management Reviews, Technical Training, Trending and Statistical Evaluation, Root Cause Analysis (RCA) through tools.NOTABLE CAREER ACCOMPLISHMENTS#Successful USFDA Pre-Approval Inspection and EMA Certification for Biologics Drug Substance at Syngene.# Successful USFDA audit after remediation at Mylan, Hosur.# Successful completion of GMP audit by COFEPRIS-Mexico with ZERO observations’ outcome.# Successful completion of GMP audit by SFDA-China without any critical observations.# ‘Zero’ overdue CAPA for regulatory observations for year 2011, 2012, 2013, 2016 & 2017. # ~25% reduction in SOPs by consolidation of similar/relevant SOPs and eliminating redundant SOPs. # Zero observations for Audit & Compliance function in first WHO-Geneva pre-qualification audit for BE.# Launch of First Recombinant Biopharma Drug Product of Gujarat and its WHO-GMP approval.