Sanjay Patel

About Sanjay Patel

Electronic batch record Execution Compliance at JB Chemical and Pharmaceuticals ltd,Green…

Experience

1. Assistant Manager

   Zydus Group

   Sep 2023 — Present · Ahmedabad, IN

   To review User requirements specifications of computer system.To review prepared Initial risk assessment for Computer System.To review prepared Validation Plan for Computer System.To review prepared Functional requirement specification for ComputerSystem.To review prepared and executed pre and post functional requirement assessment for Computer System.To review prepared Design specification for Computer System.To review prepared and executed Installation Qualification for Computer System.To review prepared and executed Operational Qualification for Computer System.To review prepared and executed Performance Qualification for Computer System.To review prepared and executed Requirement traceability matrix for Computer System.To review prepared 21CFR assessment for Computer System.To review prepared Validation summary report for Computer System.To review prepared System release certificate for Computer System.To review and execute periodical performance qualification/periodic review of software as per defined schedule.To prepare Computer system validation master plan (CSVMP).To maintain inventory list of software and hardware.To execute software data backup restoration challenge test and data mirroring challenge test as per defined frequency. To review and execute Qualification and Requalification activities of equipment, utility System and area.To review room concept and requirement document of area.To review, monitor and execute periodic review of equipment protocol.

Skills

• Ipqa of Tablets,Change Control,Filling of Log-Book,Line Clearance,Aql Analysis
• Root Cause Analysis
• Formulation
• Quality Assurance
• Change Control
• Cleaning Validation
• Issue of Logbook, Batch Record Review
• Master Document Review
• Sop
• Regulatory Affairs
• Uv
• Calibration of Different Instruments
• 21 Cfr Part 11
• Dissolution
• Pharmaceutical Research
• Hardwork
• Sap Entry
• Self Help
• Gap Analysis
• Glp
• Hplc
• Preparation of Apqr
• Capa
• Deviation Management
• Validation
• Anda
• Pharmaceutical Industry
• Gmp
• Pharmaceutics