Divyesh Soni
Pharma QA Specialist | 11+ Yrs Exp | QMS, CSV, QRM, Quality Software Implementation | Creating Engaging Pharma Content
- Role
- Qa Manager at RK Pharma Inc
- Location
- East Brunswick, NJ, US
- LinkedIn followers
- 500 followers
About Divyesh Soni
Experienced Quality Assurance professional with over 11 years of expertise in…
Experience
Qa Manager
Jan 2025 — Present · 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.
Education
Sardar Patel University (SPU), Vallabh Vidyanagar
Master of Science - MS
2012 — 2014
Sardar Patel University (SPU), Vallabh Vidyanagar
Bachelor of Science - BS
2009 — 2012
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