Ripal Bhavsar

Involved in Application Life Cycle Management; Software Design and Development align with business requirements. Create implementation or integration approach for applications and its components. Provide primary support for application releases into production, including deployment plan and schedule. Coordinate and fix defects or performance issues within Service Level Agreements. Analyze, design, build, and/or test new components or enhancements to existing modules.

Involved in all Computerized System Validation (CSV) Activities such as, • Software Validation/Qualification • Quality Management System (QMS) • CSV Documentation • Training Management • Vendor Assessment • Periodic Review • CAPA; Deviation; Investigation • SOP Preparations, Training and Implementation • Audit Support; Resolution of Audit findings

Involved in • Computer System Validation (CSV) and Documentation • Line Integration • Automation Software Testing • Software Assessment (21 CFR Part 11 & EU Annex 11) • P&ID Diagram Verification • CMMI Level 3 Documentation • CAPA; Deviation; Investigation • Expertise in Technical Operational Manual Preparation and operation of Rockwell; Siemens; Omron; Mitsubishi softwares. • Regulatory & Client Audit Support and Resolution of Audit findings • Design/Customise Lifecycle Documents Templates