Quality and Regulatory Compliance Consultant
Arunava has been working as a Senior Quality and Validation Consultant at Progress since September 2022. He has global expertise in Quality regulatory compliance and computer system Validation within the Life Sciences and Medical Device industries.
Previously, he worked as a Quality and Regulatory Informatics Validation Consultant responsible for computer system validation and system integration projects in the USA. Before, he worked in Senior Quality management roles for companies such as Aspen and Zydus Cadila. He started his career as Scientific officer and gained experience working in various Quality and Validation roles. As Quality and Compliance consultant he demonstrated high-end expertise in Qualification validation, data integrity remediation and quality system enhancements projects globally and worked with some of the leading firm as Covance Labcorp and Validant Inc,USA.
Arunava provides guidance in post FDA Warning-Letter writing, response writing and remediation projects to restore customer credibility with regulatory authorities. He gained extensive experience as a direct personal interface with international regulatory authorities and contributed to implementation projects for enhanced digital quality management systems. He supported global healthcare and start-ups embarking on digital transformation by proactively designing and optimizing the automation of quality systems.
Arunava holds a Master degree in Microbiology from Nagpur University, India, and a Quality Auditor certificate.
Arunava is married to Harshada and has a nine-year-old daughter Aniha. He enjoys photography, traveling and music.
- Quality System Enhancement and Data Integrity Audit and Remediation
- Computer system validation and software Assurance Expert
- Sterility Assurance and Contamination control Strategy
- Commissioning and Qualification Quality Engineering
- Risk Management
- Data Analytics, designing Quality Metrics and process Automation