Ishan Bhandari
Senior Validation Engineer at Marken
- Role
- Senior Validation Engineer at Marken
- Location
- El Cerrito, CA, US
- LinkedIn followers
- 500 followers
About Ishan Bhandari
7 plus years of experience in Validation with strong background in Computer System Validation, Technical Writing along with performing Manual and Automated Testing including specialization in 21 CFR part 11 compliance and GAMP, GxP’s (GMP, GLP and GCP). • Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Change Control, Decommission report, Periodic Review Report• Hands on review of the following deliverables - Regulatory Assessments, Risk Assessments, Validation Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, Validation Summary Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.• Experience in writing standard operating procedures and validation polices.• Experienced in 21 CFR Part 11, GAMP 5, GLP, GCP, GMP, CGMP and GDP guidelines.• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, investigation Task, Action, Request, Request Extension and Closure phases.• Collaborated in teams with effective, multi-tasking, critical-thinking, communication and documentation capabilities.• Excellent experience in performing pre and post approval of Test cases (IQ/OQ/PQ) and Defects.• Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards. • Proficiency in developing GAP Analysis, Redemption Plans & designing RTM\'s• Developed and implemented corrective action and preventive action plans (CAPA). • Self-Motivated individual exhibiting team spirit qualities with excellent communication and interpersonal skills able to follow instructions from validation and project leads.
Experience
Senior Validation Engineer
Jun 2021 — Present · NC, US
Education
Rhine -wall university of Applied Sciences
Bachelor of Applied Science - BASc
2012 — 2013
Trichandra multiple campus of Science and Technology
Bachelor's degree
2008 — 2012
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