Kashinath Radde
Specialist Dqa @Dr. Reddy's Laboratories
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WORK HISTORY
Specialist Dqa @Dr. Reddy's Laboratories
Hyderabad, IN
Specialist – OSD Product DevelopmentAs a Specialist in Oral Solid Dosage (OSD) Product Development, I contribute to the formulation and process design of robust, scalable, and regulatory-compliant pharmaceutical products. My role involves end-to-end development activities, from pre-formulation studies to technology transfer, ensuring product quality, efficiency, and compliance with global standards.QMS Compliance,OOS/OOT investigation methodology Nitrosamine impurity evaluation and control,Regulatory documentation and audit readiness.
EDUCATION
MVP Samaj's College of Pharmacy, Nashik
M.pharmacy, Quality Assuarance
Dr.D.Y. Patil Institute Of Pharmacy
Bachelor of Pharmacy - BPharm,Pune, Pharmaceutical Sciences
MAHATMA GANDHI COLLEGE AHMEDPUR,Latur
H.S.C, Science
ABOUT KASHINATH RADDE
Pharmaceutical Quality & Compliance Expert | 12+ Years in Oral Solid Dosage (OSD) FormsDynamic and detail-oriented pharmaceutical professional with over 12 years of experience in Oral Solid Dosage (OSD) manufacturing and quality operations. Adept at driving compliance, process excellence, and regulatory readiness across departments including Manufacturing, IPQA, DQA, QMS and QA. Technical Expertise:Document Review: Thorough review of Batch Manufacturing Records (BMR) and analytical documents for exhibit and commercial batches.Validation & Qualification: Skilled in method validation, cleaning validation, and execution of qualification protocols for equipment and systems.Process & Product Development: Active contributor to product and process development for regulatory filings in USA, Health Canada, and EU markets.Pharmacopoeial Compliance: Ensures alignment with USP, EP standards and Nitrosamine risk assessments.Sampling & Investigations: Experienced in stratified sampling, OOT/OOS investigations, and data integrity compliance.Audit Preparedness: Core member of audit compliance teams, successfully handling inspections from USFDA, MHRA, WHO, and internal audits.🧠 Professional Values:Committed to continuous learning and staying current with evolving global regulatory expectations.Strong believer in teamwork, collaboration, and knowledge sharing to drive operational excellence.
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