Dhrítí Tupe
🌍 Site Quality Head | GxP Compliance & Inspection Readiness Leader | Building Audit-Proof, Risk-Based Quality Systems | Mentor & Advisor | Certified ISO Lead Auditor
- Role
- Site Quality Head- Global Manufacturing Organisation at Dr. Reddy's Laboratories
- Location
- Mumbai, MH, IN
- LinkedIn followers
- 500 followers
About Dhrítí Tupe
Site Quality Head-OSD, Injectables, Topicals and Oncology Formulations | Pharma QA and Compliance Strategist | 23 Plus Years | Ph.D. Pharmaceutics | IAF AwardeeWith over 23 years in pharma and CRO industries, I have built my career on one belief quality is non negotiable. My expertise lies in transforming compliance frameworks into performance focused systems that protect patients, strengthen regulatory alignment, and enhance operational efficiency.Currently, I serve as Site Quality Head at Dr. Reddys Laboratories, responsible for compliance, integrity, and operational excellence across Quality Assurance and Quality Control, covering chemistry and microbiology.Key Responsibilities:• Lead capability building, recruitment, and scientific training for QA and QC teams.• Strengthen QMS aligned with cGMP GLP and global regulatory standards.• Oversee master document review, ensuring data integrity and audit readiness.• Drive investigations CAPA and deviation management with strong RCA.• Govern batch disposition risk based release and compliance of manufacturing.• Lead vendor qualification internal external audits and contract lab governance.• Oversee recall systems stability programs and pharmacovigilance linkage.• Champion continuous improvement and a culture of discipline and accountability.Previously, I led compliance systems vendor oversight and risk governance at Pfizer ensuring regulatory readiness. My earlier experience at Cipla Enem Nostrum Remedies ProPharma Group and Bio Scientific Research Laboratories strengthened my grounding in analytical chemistry QMS development and regulatory strategy.Recognized by the Indian Achievers Forum for excellence in quality and compliance, I remain committed to advancing science based risk driven and sustainable quality practices.Core Expertise:Quality Leadership | QMS Design | Regulatory Compliance USFDA EMA MHRA WHO CDSCO | Risk and CAPA Management | Data Integrity | Product Lifecycle | Audit and Inspection Management | Quality Culture | Digital Quality Systems | Lean and Continuous Improvement | Tech Transfer | Change Control and ValidationPh.D. Pharmaceutics | Lean Six Sigma | ISO 90••••15 Lead Auditor | CQA | IRCAQuality is not just my responsibility it is my philosophy. I consistently focus on building resilient teams strengthening site readiness and driving proactive quality measures that ensure long term compliance and operational reliability. My leadership approach blends scientific rigor with practical execution enabling robust quality systems. Guides excellence!
Experience
Site Quality Head- Global Manufacturing Organisation
Oct 2025 — Present · IN
Education
University of Mumbai
Doctor of Philosophy - PhD, Pharmaceutics
IPM Business School
Postgraduate Degree, Regulatory affairs
St Annes High School
SSC
University of Mumbai
Master of Business Administration - MBA, Total Quality Assurance and Clinical Research
Mumbai Educational Trust, MET League of Colleges
Bachelor of Pharmacy - BPharm
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