Vijay Suthari

About Vijay Suthari

Versatile achievement driven pharmaceutical professional with around 24+ years of rich…

Experience

1. Site Head, Quality

   Dr. Reddy's Laboratories

   Jun 2013 — Present · Hyderabad, IN

   Heading QA/QC functions and manage all regulatory, customer and internal audits to maintain highest levels of quality operations.• Establish and maintain quality systems meeting cGMP/cGLP standards and meeting all statutory compliances. Enhance organizational competencies by training and develop quality and manufacturing personnel.• Review and approval of green field, brown field projects in coordination with various stake holders.• Ensure effective management of deviations, market complaints, change control, OOS, IQ/OQ documentation, facility qualifications, process validations, technology transfers, MES, eBPRS, analytical method validations and other quality systems.• Approve process, equipment, facility and analytical validation requirements/protocols/reports, QA investigations, and annual product reviews, procedures, stability protocols/reports and cGMP control documents.• Manage change Control programs including the CAPA program to ensure that changes affecting marketed product are documented, evaluated and implemented.• Define, raise and measure key and quality performance indicators for assigned Operating Units.• Ensure implementation of Dr Reddys Quality System within the assigned Operating Unit such as Quality Manual, Global and Central Standard Operating Procedures etc.

Skills

• Risk Analysis
• Cleaning Validation
• Quality Auditing
• Risk Management
• Hplc
• Quality System
• Quality Systems
• V&V
• Verification and Validation (V&V)
• Risk Assessment
• Good Laboratory Practice (Glp)
• Quality Control
• Gmp
• Regulatory Affairs
• Risk Mitigation
• U.s. Food and Drug Administration (Fda)
• Formulation
• Quality Management
• Analytical Method Validation
• Technology Transfer
• Glp
• Pharmaceutical Industry
• Fda
• Validation
• Quality Assurance