Namonarayan Singh

WORK HISTORY

EDUCATION

SKILLS

ABOUT NAMONARAYAN SINGH

Results-oriented Assistant General Manager – Corporate Quality Assurance (CQA) with 18 years of progressive experience in the pharmaceutical industry, specializing in Quality Assurance, Quality System Auditing, and global regulatory compliance. Proven success in leading quality initiatives that enhanced compliance, reduced audit observations by 60% across 20+ USFDA and global regulatory audits, and strengthened organizational quality culture.I offer a unique blend of strategic leadership, technical expertise, and regulatory insight, with a strong track record in managing QMS, data integrity, OOS investigations, deviations, CAPA, product recalls, vendor management, and regulatory query handling. I am skilled in 21 CFR Part 211, 21 CFR Part 11, Annex 11, and guidelines from WHO, EMA, and MHRA.With hands-on expertise in analytical techniques (HPLC, GC, FTIR, UV, LCMS, ICPMS, XRPD, NMR, etc.), audit trail review, and data integrity assessments, I have successfully supported regulatory readiness, quality remediation, and compliance oversight for API, formulations (OSD), biotech, and contract manufacturing sites across India and China.As a certified Lean Six Sigma Green Belt and holder of an MBA in Operations Management along with M.Sc in Organic Chemistry, I combine scientific rigor with business acumen to drive quality excellence, operational efficiency, and sustainable compliance strategies.I have developed strong teamwork skills, and enjoy such an environment; throughout my education and experience exhibited sheer hard work, sincerity and determination & earned strong analytical abilities(HPLC, GC, FTIR, UV, Dissolution Apparatus, XRPD,ICPMS,GCMS,LCMS,IC,NMR etc.),Electronic Data Review-21CFR PART 11,Audit Trail Review,Quality Management System-OOS, Deviation, Lab Event,Change Control, Market complain, CAPA, QRM,CSV, Regulatory Updates, Product Development Report, Analytical Method Validation & Analytical Method Transfer, Process Validation, BMR Review, IPQA, ANDA Review, Instrument Qualification, Stability, Data Integrity, cGMP Audit Management, Vendor Management, Contract manufacturing,Self Inspection, Project Management, Capacity Enhancement, Business continuity, Regulatory Query and solution, Desktop Audit, Virtual Review. This is a trend that I intend to continue long into the future.I am passionate about building high-performing teams, driving continuous improvement, and ensuring patient safety through uncompromised quality standards.