Anup Kore

About Anup Kore

Pharmaceutical Quality Innovator | Turning Compliance into Competitive Advantage7+ Years • 99% Success Rate • Zero Non-Conformities • 100% EU-GMP ComplianceWhat if quality wasn\'t just about meeting standards, but about setting them?I\'m the quality leader pharmaceutical companies call to transform operations from reactive compliance to proactive excellence. With a proven track record of flawless results while driving innovation, I turn quality challenges into strategic opportunities. The Results Speak Louder Than Words Perfect Execution:100% EU-GMP compliance across all operations—no exceptions99% APQR/PQR success rate turning reviews into improvement enginesZero non-conformities in 7+ years—testament to proactive quality culture100% batch accuracy with streamlined processes Data-Driven Innovation:I don\'t just collect data—I unlock its power. Using Power BI analytics and LIMS implementations, I\'ve transformed how teams visualize trends, predict issues, and make impactful decisions. My Secret Sauce: Where Strategy Meets ExecutionThe Quality Revolutionary: While others see compliance as burden, I see it as foundation for excellence. I build systems that don\'t just pass audits—they become competitive advantages.The People Developer: As certified trainer and SME, I transform teams. From CMO standardization to capability building, I create quality cultures that sustain long-term.The Problem Solver: Complex validation, critical batch review, vendor audit crisis—I thrive where others struggle. My approach combines technical expertise with strategic thinking and innovation. What I Bring: Technical Mastery: Quality Systems • Batch Release • Validation • IPQA • EU-GMP • CAPA • Artwork Strategic Innovation: Power BI Analytics • LIMS Leadership • Data Integrity • Process Optimization Leadership Excellence: Team Development • Training Design • Cross-functional Collaboration Business Impact: Audit Success • Vendor Management • Customer Relations • Risk Mitigation Ready to Revolutionize Your Quality Operations?I partner with forward-thinking pharmaceutical companies who understand exceptional quality isn\'t just compliance—it\'s creating sustainable competitive advantages driving growth, innovation, and patient trust.The question isn\'t whether you can afford quality excellence—it\'s whether you can afford not to.Let\'s connect and transform your quality challenges into greatest strengths.\"Quality is not an act, but a habit. Excellence is not a destination, but a journey.\"- Living this philosophy daily.

Experience

1. Global Qualification and Validation Senior Specialist

   Sanofi

   Aug 2025 — Present · Hyderabad, IN

   Subject Matter Expert (SME) in Equipment & Process Validation and Cleaning Validation, with proven expertise in meeting global regulatory standards (GMP, FDA, EMA, WHO) while driving operational excellence. Skilled in reviewing and approving qualification and validation documentation, conducting equipment qualification and leading process and cleaning validation activities. Experienced in failure investigations, root cause analysis, and implementing effective CAPAs to prevent recurrence. I combine technical expertise with strong problem-solving, training, and cross-functional collaboration to embed best practices and optimize validation programs for compliance, efficiency, and sustainability. Staying ahead of industry trends and evolving regulations, I translate knowledge into practical strategies that strengthen quality systems, ensure audit readiness, and enhance product quality in dynamic manufacturing environments.

Education

• University of Mumbai

  Bachelor of Pharmacy - BPharm, Pharmacy

  2016 — 2018

• Tatyasaheb Kore College of Pharmacy, WARANANAGAR

  DIPLOMA IN PHARMACY, Pharmacy

  2013 — 2015

• Indian Institute of Business Management & Studies

  Master of Business Administration - MBA, Logistics, Materials, and Supply Chain Management

  2019 — 2021