Siddharth Khirdikar
Validation Engineer at Rockwell Automation
Based in Pune District, India
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Seniority
Staff
Department
Information Technology
Location
Pune District
Industry
Automation Machinery Manufacturing
Company size
23K
Contact information
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s•••••••@rockwellautomation.com
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Background
About Siddharth Khirdikar
5 years of experience in Computer System Validation (CSV) with hands-on GAMP 5, GxP systems, V model, SDLC, 21 CFR part 11, EU Annex 11, ALCOA+ principles.* Engaged with the Ireland Validation team to execute end to end pharmaceutical validation projects for US & Europe region.* Development & execution of CSV deliverables as VP, FAT, SAT, IQ, OQ, PQ, RTM, Summary Report.* Review & approval of test protocols adhering to the CSV procedures as test sheet completion, Deviation log, CAPA, CC.* Development of documents such as Proposal document, URS, GAP assessment, Risk Assessment, Project Automation Requirements checklist for the IT application, L2 integration project.* To prepare new SOP.* Experience in handling Regulatory Audits like USFDA, CGMP.* Good Exposure in Handling Quality Management System (QMS) tools complying to the guidelines.* Along with the CSV, also has 3 years of experience in Project Automation & Production with hands on PLC, HMI programming developmente for the pharmaceutical projects.
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