A Pharma professional with extensive experience in the areas of domestic and international regulations, has over 30 years ’experience in Pharma Industry and is well versed in manufacturing and quality systems. Held senior management positions in QA,Manufacturing, QC and Regulatory Affairs Worked in the Pharmaceutical industry to develop quality assurance and regulatory strategies for compliance with stringent regulatory authorities such as US FDA, MHRA, EMA, PMDA and others Experience includes support for process development, technology transfer, assisting with remediation activities, especially on CAPAs, root cause analysis. Conducted GMP assessment of facilities and support to help companies address quality systems deficiencies.