PRASUN CHAKRABORTY — Associate Partner
Global Quality & Compliance Leader with 20+ years of experience building FDA-ready, inspection-resilient pharmaceutical organizations. I am a senior Quality, Compliance, and Capability-Building professional with extensive experience across multinational pharmaceutical manufacturing environments supporting regulated markets including US FDA, EMA, MHRA, and CDSCO. I have a strong track record in US FDA Warning Letter remediation, inspection readiness, and the design of sustainable pharmaceutical quality systems that consistently deliver compliant outcomes. My experience spans sterile and non-sterile manufacturing, APIs, and complex global supply chains. I specialize in translating complex regulatory requirements into practical, executable quality systems that strengthen operational performance while reducing regulatory risk. Core Expertise • Global Quality Systems (QMS) & GMP Compliance • US FDA, EMA, MHRA, CDSCO regulations • FDA 483 response & Warning Letter remediation • Inspection readiness & audit management • CAPA, Deviation Management & Quality Risk Management • Data Integrity (ALCOA+) • Learning Management Systems (LMS) & capability building • Human Error Prevention (HEP) & quality culture transformation • Change leadership across multi-site operations Key Contributions • Led remediation programs for FDA-regulated sites, restoring compliance and regulatory confidence • Delivered zero-critical observation outcomes through robust inspection readiness strategies • Built and scaled enterprise-wide training and capability frameworks to support sustainable compliance • Partnered with senior leadership to align quality strategy with business and growth objectives • Strengthened quality culture through people-centric, risk-based approaches I am recognized for my ability to connect quality, people, and performance—moving organizations from reactive compliance to confident, inspection-ready operations. Leadership Approach I believe compliance is sustainable only when it is embedded into behavior, capability, and decision-making, not driven by documentation alone. My leadership style is collaborative, data-driven, and focused on long-term system maturity.
Stackforce AI infers this person is a Quality and Compliance Leader in the Pharmaceutical industry.
Location: Bengaluru, Karnataka, India
Experience: 23 yrs 8 mos
Skills
- Global Quality Systems (qms) & Gmp Compliance
- Fda 483 Response & Warning Letter Remediation
- Learning Management Systems (lms)
Career Highlights
- 20+ years in global quality and compliance leadership
- Expert in FDA warning letter remediation
- Proven track record in building sustainable quality systems
Work Experience
Viatris
Deputy Director (3 yrs 2 mos)
Associate Director I (3 yrs 11 mos)
Associate Director II (3 yrs)
Intas Pharmaceuticals
AGM-Compliance Training (2 yrs)
Hospira
Quality Assurance Manager (7 mos)
Sun Pharmaceutical Industries Ltd
Corporate Quality Learning & OD Manager (2 yrs 11 mos)
Merck KGaA, Darmstadt, Germany
Corporate Quality Assurance Executive (3 yrs 4 mos)
ratiopharm
Research Scientist (1 yr 11 mos)
Glenmark Pharmaceuticals
QA Officer (1 mo)
Cipla Ltd
QC Officer (1 yr 11 mos)
MEDICORE LIMITED
QC /QA Officer (11 mos)
Education
at MBA – Narsee Monjee | M.Tech – BITS Pilani
Master of Business Administration - Human Resource Management at SVKM's Narsee Monjee Institute of Management Studies (NMIMS)
Master of Technology - MTech at Birla Institute of Technology and Science, Pilani
ISTD diploma at Indian Society for Training & Development (ISTD)
Advanced diploma in Professional Development in Training at World TESOL Academy
M.Sc at Doctor Babasaheb Ambedkar Marathwada University
HSC at Bidhan chandra institue,durgapur
