Harendra Kumar Mourya

About Harendra Kumar Mourya

Every failure is the opportunity to improve further if we investigate it thoroughly.\"- from W. Edwards DemingQuality Compliance Leader | Six Sigma Black Belt | Pharmaceutical & Healthcare Quality Expert15+ Years Driving Quality & Regulatory Compliance - QMS, RCA & Continuous Improvement | Open to Senior Quality Roles.Results-Driven Impact: QMS Management of API, OSD and External Preparation Product. CMO Quality Compliance, Vendor-Qualification/ Audit and Project Management. Expert in Root Cause Analysis (RCA) & CAPA Execution—turning failures into sustainable quality breakthroughs. QMS Architect—overhauled Change Control, Deviations, OOS/OOT, and Market Complaint systems, ensuring 100% regulatory alignment. Supervised timely accomplishment of APRs/ PQRs documentation by implementing statistical tools (Capability Analysis, Trend Analysis, Control Charts) which enhancing complaint during regulatory audit. Proven Audit & Compliance Leader—successfully managed US FDA, MHRA, TGA, ANVISA, and CDSCO inspections with zero critical observations. Lean Six Sigma & DMAIC Specialist—optimized processes, slashed risks, and boosted QC lab efficiency by 30%+ through Lean Lab & 5S initiatives. Data-Driven Strategist—leveraged MIS reporting, Gemba walks, and vendor qualification to drive operational excellence.Key Achievements: Eliminated recurring deviations by deploying advanced RCA tools (DMAIC, FMEA, 5 Whys) and human error reduction programs. Mentored APRs/ PQR document with compliant of Regulatory norms Pioneered training innovations (video/visual aids) that cut analyst errors by 40% and accelerated competency. Led NABL accreditation and Six Sigma projects, making manufacturing processes more robust and inspection-ready. Championed Lean Lab & 5S—transforming labs into high-productivity, audit-proof environments.Mission: To fuse compliance with innovation—ensuring quality isn’t just met but mastered. Let’s Collaborate!Reach me at h•••••••@gmail.com or connect here to discuss quality transformation, audits, or operational excellence.

Experience

1. Manager- Corporate Quality and Regulatory Compliance

   Schülke & Mayr

   Jan 2018 — Present · Mumbai, IN

   Led CMO Audit and QMS compliance for Contract manufacturing sites, aligning with global regulatory standards (US-FDA, MHRA, TGA, ANVISA, CDSCO). Spearheaded Quality Investigations, overseeing Change Controls & Deviations management, Market Complaints, OOS/OOT/OOE cases, and implementing effective CAPA to prevent recurrence. Optimized Quality Operations through Lean Lab initiatives, 5S implementation, and Gemba walks, enhancing efficiency, audit readiness, and compliance at the site. Accomplished 30% reduction in failure events (OOS, deviations, incidents) through a proactive approach and effective CAPA implementation, ensuring compliance and process robustness. Achieved 30% reduction in market complaints through strategic CAPA implementation, enhancing product quality and customer trust. Reduced analytical instrument breakdowns by 20%(HPLC, GC) through the implementation of effective Good Practices, enhancing lab efficiency and reliability. Drove Data-Driven Decisions, utilizing Six Sigma tools (Gauge R&R, Capability Analysis, Control Charts, Trend Analysis, ANOVA, Time series) for APQR, AMV, Stability Data, Validation, and QMS Metrics. Championed Vendor & Tech Transfers, leading API vendor qualification, technology transfer, and validation processes for seamless integration. Strengthened Regulatory Readiness, collaborating with R&D, Production, and ADL, and interfacing with US-FDA, MHRA, TGA, ANVISA, and CDSCO for audits and compliance. Spearheaded Product Compliance, strategizing APCA region product registration, liaising with local FDA (CDSCO), and ensuring seamless regulatory approvals.

Education

• Indian Institute of Technology, Roorkee

  M.Tech (Advance Chemical Analysis), Chemistry

  2008 — 2010

• MJP Rohilkhand University Bareilly U.P.

  M.Sc, Organic Chemistry