Computer System Validation &
Computer Software Assurance

Organizations worked

Sun Pharma, Alembic, Blue Cross Laboratories, Zydus Cadila, Titan Laboratories, USV, Astra Zeneca, Sanofi & Mylan

A Quality oriented professional with over two decades of experience in production, quality assurance, quality control, quality engineering, quality auditor, pharmaceutical regulations and regulatory audit compliance.

His area of expertise includes USFDA, EUGMP, PICS, MHRA, TGA, TPD, ANVISA, WHO & Schedule-M Guidelines.

The key competencies include, quality compliance, suppliers audit, build systems to encourage compliance with the principles of data integrity, computer system validation, training, risk assessment, facing the audits, preparation and review of audit compliance, qualification & validation, system development for CAPA effectiveness, stability studies & solving pre approval or post approval queries raised by regulatory agencies etc.

He has independently handled production, quality assurance and quality control department for more than 13 years. During tenure audited more than 500 endors/suppliers and trained more than 3000 candidates. Expertise in to preparation, review of FDA 483/Warning Letter response.