Jaikishen Kanagasabai
Hyderabad
Summary
3 years of experience as Computer System Validation Expert in Regulatory Compliance and Quality Assurance consulting using a risk-based approach for Healthcare and Life Sciences Clientele as per US FDA 21 CFR part11, EU Annex 11, GAMP5
Overview
3
3
years of professional experience
Work History
Junior Solution Analyst
Deloitte USI
Hyderabad
09.2022 - Current
- Ensured end to end compliance of GxP Projects as per FDA title 21 CFR part 11, 210, 211, EU Annex 11, V-Model and GAMP 5 guidelines for multiple projects like SAP ERP a, lead SOX based Treasury Management System to multiple deployments.
- Spearheaded the Quality Assurance efforts for the successful data migration of SAP ERP from the parent company and a newly acquired entity. Led end-to-end testing processes, including data validation over multiple deployments and issue resolution. Collaborated closely with cross-functional teams to ensure data integrity, minimize system downtime, and ensure smooth transition of business-critical data.
- Led the QA strategy and execution for the implementation and ongoing optimization of the Treasury Management System (TMS), ensuring full functionality and alignment with financial operations. Collaborated closely with the Treasury, IT, and business teams to ensure system compliance with internal policies and SOX regulatory requirements, with a focus on audit trails and financial controls.
- Streamlined quality processes and documentation as per customized project requirements and feasibility (CI/CD, Agile, Waterfall)
- Requirement Analysis for ERP and cloud-infrastructure projects for CSV (IQ, OQ, PQ)
- Performed root cause analysis(RCA) using FMEA and impact analysis of newer projects and their respective deviations
- Created multiple documents such as Quality Assurance Plan, Data Migration Plan, Quality Assurance Summary Report with Release Authorization Note,Data Migration Summary Report, Traceability Matrix, System change movements via SolMan as well as ServiceNow
- Managed a team of 4 on client-side for quality assurance and CSV process alignment
- Onboarded and coached multiple new CSV resources to projects
Education
Secondary -
Padma Seshadri Bala Bhavan Senior Secondary School
Chennai01-2016
Senior Secondary -
Lalaji Memorial Omega International School
Chennai01-2019
Bachelor of Computer Applications -
SRM Institute of Science And Technology
Ramapuram01-2022
Skills
- Data Analysis using excel
- Risk Assessment (FMEA)
- Functional Testing and Data Migration
- GDP, ALCOA and CSV checks
- Code Scripting in Python, C, C,HTML,CSS
- UI/UX Design
Tools/Technologies
- HP ALM
- ServiceNow
- SolMan
- JIRA
- Confluence
- qTest
- Excel and other office tools
Languages
Tamil
First Language
English
Proficient (C2)
C2
Hindi
Intermediate (B1)
B1
Affiliations
- Worked with NGOs in Deloitte as a cluster lead to provide sessions for underprivileged women in Hyderabad.
- Was part of the Management Committee for the TechBlaze event in SRM.
Timeline
Junior Solution Analyst
Deloitte USI
09.2022 - Current
Secondary -
Padma Seshadri Bala Bhavan Senior Secondary School
Senior Secondary -
Lalaji Memorial Omega International School
Bachelor of Computer Applications -
SRM Institute of Science And Technology
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