Prathamesh Gawade
Computer System Validation Specialist at Alten India
Based in Pune, India
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Seniority
Staff
Department
Engineering
Location
Pune
Industry
Engineering Services
Company size
2.2K
Contact information
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p•••••••@alten-india.com
Phone
5 credits+91 ••• •••• ••••
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Background
About Prathamesh Gawade
PLC Programmer in Rockwell, Siemens and Mitsubishi Platform 2. SCADA Programmer in Zenon (COPA-DATA) platform, HMI Programmer in Weintek Platform. PLC programming validation based on GAMP Software Categories. Development of logic independently with reference to design documents, functional testing of Studio instructions through Ladder diagram for multiple MNC client projects. Batch Control Development in SCADA based on ANSI/ISA-88 Standards. Review of P & ID, Electrical Drawing (E-plan), Cause & Effect Diagrams, Instruments lists, Flow chart. Carry out system testing against specifications, record test results and review test results in line with current validation regulations e.g. GAMP, 21 CFR Part 11. Modify, review and create Validation documents, Quality Plans, Specifications, Validation reports. Responsible for computerized system validation of PLC & SCADA systems as per 21 CFR part 11 compliances & GAMP Guidelines as well as responsible for SAP Validation. Responsible for Software development Life Cycle (SDLC) including requirement gathering, designing & documenting functional specifications activities and testing. ISO Auditor and Departmental Lead Assessor. Excellent communication skills, client-facing skills and have participated in proposals and presentations.
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