Archit Bhatt

Background

About Archit Bhatt

A dynamics Validation professional with over 12 years of comprehensive Hands-on experience in Automation Commissioning and Computerized System Validation. Having experience for development and review for CSVMP master validation plan for the GAMP 5 category machines as per 21 CFR part 11 compliance for Analytics, Manufacturing & Engineering equipment’s. Well versed in CSV with experience in FDA (GxP, 21 CFR Part 11, data integrity), EU Annex 11, GAMP 5, and other regulatory compliance and adherence. Infrastructure Qualification for IT servers/client systems. Expertise in GAP assessment and mitigation plan in-line with 21 CFR Part 11, data integrity and GxP. Checking the Functions like Audit Trail, Print Report, Alarms, Interlocks, Data Integrity, Data Backup & Restore, I/O’s, Security Policy, Communication Loss and Power Failure based on 21 CFR Part 11, GAMP5 and cGMP Guidelines. Ability to manage, schedule, communicate and collaborate with stakeholders including follow-up on Vendor deliverables and services according to agreements. Professional in validation activities related to standalone and networked laboratory instrument software, Manufacturing systems (PLC and SCADA) and Enterprise Application (SAP Modules). Expertise in change and incident management, periodic review of GxP systems. Planning and performing the periodic review of computerized systems. Exposure on generation, maintenance & revision of SOPs, protocols, training and other documentation. Technical exposure on conducting FAT, SAT and Impact Assessment at vendor’s site and plant site. Skilful knowledge of Change Control, Deviations, Non-conformances and CAPA management. Significant exposure in several audits such as USFDA, MHRA, TGA and other regulatory bodies.Designing the complete PLC and SCADA system. Experience in troubleshooting, debugging, supporting & coding programs in process & discrete logic. reparing Functional and detailed design specifications.