Rupali Thorat

About Rupali Thorat

Quality Assurance leader with 16+ years of experience in the pharmaceutical industry, currently serving as Division Manager – Quality Assurance at Abbott. I lead quality compliance oversight for 110+ Third Party Manufacturers (TPMs), ensuring compliance, robust quality systems, and consistent adherence to Abbott standards for complaint coordination, Quality Technical Agreement, Product Quality Report (PQR) reviews including executive quality reporting, risk control plan evaluations, status information reporting as per approved dossier and electronic document control. I partner closely with cross-functional teams to proactively identify, escalate, and mitigate quality risks.I specialize in Quality Management Systems (QMS), including electronic documentation systems, eLMS platforms, and Track-wise deviation and complaint modules. As a Subject Matter Expert, I support internal stakeholders in driving system efficiency and regulatory compliance.I act as Divisional Coordinator for Culture of Quality Diagnostics across 20 manufacturing sites, contributing to continuous quality improvement across manufacturing and I&D operations. My role also includes overseeing divisional procedures for emerging markets, coordinating audit readiness and team qualifications, and driving strategic initiatives to strengthen quality governance across Abbott’s global operations.

Experience

1. Division - Manager Quality Assurance

   Abbott

   Apr 2025 — Present · Mumbai, IN

   Division Quality System and Strategy.Management of TPMQA Quality Management Systems- Complaint Coordination- Complaint Sample management- Status Information of Regulatory Changes (SIR) report review and distribution of documents to respective TPMs- Review of Product Quality Review Report and Preparation of Executive Review Report Summary- Preparation of Quality Technical Agreement and tracking of due date- Uploading and approval of documents via electronic document management system - SME for Culture of Quality Diagnostics for all Manufacturing sites and I&D Center- Divisional Procedure review and coordination for Business Unit - Emerging Market- Personal Qualification coordinator for Divisional: Audit and Compliance Team

Education

• Academy of Clinical Research, Bombay college of Pharmacy, Santacruz

  PG Diploma In Clinical Research, PG Diploma in Clinical research

  2009 — 2010

• Satara College of Pharmacy , Satara

  Bachelor of Pharmacy (B.Pharm.), B.Pharmacy

  2004 — 2008

Skills

• Quality System
• Pharmaceutics
• Outlook
• Regulatory Submissions
• Management
• Research
• Manufacturing
• Regulatory Affairs
• Quality Control
• Gmp
• Testing
• Documentation
• Change Control
• Pharmaceutical Industry
• Sop
• Analytical Skills
• Regulatory Requirements
• Capa
• Validation
• Quality Assurance