Experience

CASI Pharmaceuticals, Inc.

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Senior Validation Engineer

  • Jan 2022 - Present

  •Executed and managed validation protocols, including IQ, OQ and PQ, resulting in successful compliance outcomes. •Conducted the risk assessment and developed validation plans for equipment and process ensuring alignment with regulatory expectations. •Analyze validation results, identify deviations or issues, and work collaboratively to develop and implement corrective and preventive actions. •Led validation through successful FDA inspection, demonstrating comprehensive knowledge of pharmaceutical validation principles. Show less



Bayer

• Chemical Manufacturing
• 700 & Above Employee

• Validation Lead

  • Sep 2019 - Dec 2021

  •Design, excute,manage and implement of QC instrument/software qualification like, URS, validation plans, equipment IOQ, Configuration specifications, qualification summary reports. •Handled Empower system downtime, creation of new project, new user creation, new user lock/unlock and user removal. Also handled empower related deviations. •Perform audit trail activity with data integrity team. Ensure the audit trail activity performed well with proper documentation. •Own change control specification to the specific to the qualification of QC instruments and associated software. Show less



Torrent Pharmaceuticals Ltd

• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer

  • Sep 2016 - Aug 2019

  •Develop and implement validation strategies, including process, equipment, and cleaning validation, in compliance with FDA and international regulatory guidelines. •Collaborate with cross-functional teams, including Quality Assurance, Research and Development, and Production, to drive process improvements and resolve issues. •Investigate and troubleshoot process deviations and quality issues, implementing corrective and preventive actions (CAPA) as necessary. •Provide training to production and quality personnel on validation procedures and best practices. •Validation and compliance of all lab equipment, Including validation documentation IQ/OQ/PQ. •Perform Administrative activity in Track wise and Neogenesis like, creating new user, lock and unlock users, Proxy users. Show less