Divyesh Soni

Qa Manager @RK Pharma Inc

NY, US

As a Quality Assurance professional, I am responsible for:Reviewing Process Development Reports to support process improvements and compliance.Reviewing and managing Quality Management System (QMS) documents, such as Change Control, CAPA, OOS, Deviations, and other key documents.Actively participating in customer and regulatory audits, providing support to the Head of Quality during audits.Managing Vendor Qualifications and conducting vendor and contract laboratory audits to ensure compliance and quality.Reviewing Master Batch Records, Equipment Cleaning Records, Process Flow Diagrams, and Standard Operating Procedures (SOPs) to ensure adherence to quality standards.Preparing and reviewing Process Validation, Cleaning Validation, Hold Time Protocols, Reports, and all quality-related documentation.Developing and reviewing Validation Master Plans to ensure comprehensive validation strategies.Evaluating Equipment Qualification Documents and Annual Product Reviews (APR) to maintain regulatory compliance.Ensuring the accuracy of Calibration and Preventive Maintenance Documents.Overseeing Technology Transfer processes, including the review of Technology Transfer Documents and coordination of activities.Analyzing Analytical and Microbiological Data to support Certificates of Analysis (COA), stability studies, and validation efforts.Allocating Equipment/Instrument IDs and managing proper tracking.Assisting with internal audits to ensure continuous quality improvement.Preparing and reviewing Annual Product Reviews (APR) while providing oversight of manufacturing process operations and ensuring quality support for manufacturing.Reviewing Warehouse-related documents for compliance with best practices.

Sardar Patel University (SPU), Vallabh Vidyanagar

Master of Science - MS

Sardar Patel University (SPU), Vallabh Vidyanagar

Bachelor of Science - BS