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RACHITA BANGALI

EY | CSM® | Ex-Deloitte USI | IIM Calcutta EGMP l Life Sciences | CSV & Data Integrity | Digital Transformation | Strategy & Consulting

Bengaluru

7+ years of work experience

EY
Oct 20251 yr 1 moPresent

• Led risk-based Computer System Validation (CSV) for GxP computerized systems in global life sciences programs, ensuring compliance with 21 CFR Part 11 and EU Annex 11 while supporting business timelines. • Owned end-to-end validation lifecycle activities—intended use definition, risk assessment, requirements review, testing strategy, traceability, and validation summary—focusing on regulatory intent and operational impact. • Advised client stakeholders on balancing compliance, risk, and speed-to-market, translating regulatory expectations into practical, business-aligned validation approaches. • Reviewed URS, functional/design specifications, and validation strategies, enabling scalable and audit-defensible system implementations. • Supported digital and automation initiatives (including RPA) in regulated environments by defining governance and validation models that improved efficiency without compromising compliance. • Strengthened data integrity and inspection readiness through proactive risk identification, ALCOA+-aligned controls, and clear audit response strategies. • Collaborated with cross-functional teams (Quality, IT, Business, Vendors) and mentored junior consultants, driving consistent delivery quality and client confidence.
EY
Jan 20241 yr 11 mosNov 2025

Bengaluru, Karnataka, India

• Supported end-to-end validation of cloud migration initiatives for AI-enabled GxP and non-GxP bots, contributing to regulatory compliance while enabling scalable digital adoption. • Assisted in translating high-level transformation goals into executable project plans, supporting dependency mapping, timeline estimation, and effort planning to enable efficient delivery. • Contributed to day-to-day project execution by coordinating with cross-functional teams, ensuring deliverables met quality expectations and agreed milestones. • Supported stakeholder communication and reporting, preparing project status updates, risk summaries, and change impacts to maintain alignment with program objectives. • Participated in risk assessments and mitigation activities, helping identify delivery and compliance risks and supporting the implementation of agreed control measures.
Deloitte USI
May 20239 mosJan 2024

Hyderabad, Telangana, India

• Leading team and engaged with multiple stakeholders to ensure successful client delivery. • Coached and mentored the team members on IT Quality concepts. • Drafting planning documents and final reports for GxP projects. • Revamped and standardized the client project status reports for workforce optimization using MS-Excel and SharePoint. • Hands on experience with deliverables approvals in Asset Management, ServiceNow and JIRA. • Experience in working in tools such as Jira, Veeva Vault, HP ALM, Asset Management, Qtest, ServiceNow. • Authored on system validation deliverables like Compliance Analysis, Compliance plan, Compliance summary report. • QA/QC review of end to end SDLC documentation including User stories, Change Control documents, test plan & report, Trace Matrix. • Expertise in Functional, Regression, Integration, User Acceptance Testing and Defect Management Life Cycle. • Conducted KT (Knowledge Transfer) sessions and boot camps for the newly hired members, and Training them on multiple projects.
Deloitte USI
May 20212 yrs 1 moMay 2023

Bengaluru, Karnataka, India

• Authored end to end SDLC deliverables for retrospective validation including Plan, User Stories, Risk Assessment, Scripts, Traceability Matrix, Report. • Conducted and facilitated manual testing (usability, functional, user, and regression) using Jira tool. • Training new team members on SDLC practice, QCSV review and different validation tools used. • Actively involved in project Kick off calls and status calls to clients. • Interacting with Business and Technical Owners and helping them for review/approval of the documents.
Deloitte USI
Jun 20192 yrsMay 2021

Bengaluru, Karnataka

* Performed end to end testing of lifecycle management product. * Review of end to end SDLC documentation. * QC Review of Change Requests (RFC’s) and Design Verification Plan. * Approval of SDLC deliverables to ensure that procedures and methodologies are followed and that appropriate and complete documentation is captured and reported to support SDLC. * Practical working Knowledge of tools like SharePoint, MS-Excel (Advanced). * Client Management – Interacting with Client on a daily basis to ensure seamless delivery and escalating any risks/issues to the leadership.
Bhilai Steel Plant, SAIL
May 20172 mosJun 2017

RACHITA’s AI Stack

aistudio
aistudio
claude code
claude code
gemini
gemini
metaai
metaai
midjourney
midjourney
openai
openai

Education

Indian Institute of Management, Calcutta

Executive MBA, Business Administration and Management, General

Indian Institute of Management, Calcutta

20221 yr2023
Kalinga Institute of Industrial Technology, Bhubaneswar

Bachelor's degree, Electrical and Electronics Engineering

Kalinga Institute of Industrial Technology, Bhubaneswar

20154 yrs2019

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Headline

EY | CSM® | Ex-Deloitte USI | IIM Calcutta EGMP l Life Sciences | CSV & Data Integrity | Digital Transformation | Strategy & Consulting

About

Life Sciences professional with nearly 7 years of experience across computer system validation (CSV), data integrity, and digital transformation in regulated pharma environments. Experienced in supporting global clients through consulting engagements, with a strong focus on risk-based compliance, automation enablement, and business impact. I bring a structured, consulting-oriented mindset and enjoy working at the intersection of life sciences, strategy, and transformation. Open to opportunities in CSV / Quality / Data Integrity as well as Life Sciences Strategy & Consulting roles in India and Europe.

Location

Bengaluru

AI stack

aistudio

claude code

gemini

metaai

midjourney

openai

Work experience

Senior Consultant at EY, Oct 2025 - Present · 1 yr 1 mo, • Led risk-based Computer System Validation (CSV) for GxP computerized systems in global life sciences programs, ensuring compliance with 21 CFR Part 11 and EU Annex 11 while supporting business timelines. • Owned end-to-end validation lifecycle activities—intended use definition, risk assessment, requirements review, testing strategy, traceability, and validation summary—focusing on regulatory intent and operational impact. • Advised client stakeholders on balancing compliance, risk, and speed-to-market, translating regulatory expectations into practical, business-aligned validation approaches. • Reviewed URS, functional/design specifications, and validation strategies, enabling scalable and audit-defensible system implementations. • Supported digital and automation initiatives (including RPA) in regulated environments by defining governance and validation models that improved efficiency without compromising compliance. • Strengthened data integrity and inspection readiness through proactive risk identification, ALCOA+-aligned controls, and clear audit response strategies. • Collaborated with cross-functional teams (Quality, IT, Business, Vendors) and mentored junior consultants, driving consistent delivery quality and client confidence.

Senior at EY, Jan 2024 - Nov 2025 · 1 yr 11 mos, Bengaluru, Karnataka, India, • Supported end-to-end validation of cloud migration initiatives for AI-enabled GxP and non-GxP bots, contributing to regulatory compliance while enabling scalable digital adoption. • Assisted in translating high-level transformation goals into executable project plans, supporting dependency mapping, timeline estimation, and effort planning to enable efficient delivery. • Contributed to day-to-day project execution by coordinating with cross-functional teams, ensuring deliverables met quality expectations and agreed milestones. • Supported stakeholder communication and reporting, preparing project status updates, risk summaries, and change impacts to maintain alignment with program objectives. • Participated in risk assessments and mitigation activities, helping identify delivery and compliance risks and supporting the implementation of agreed control measures.

Solution Delivery Advisor at Deloitte USI, May 2023 - Jan 2024 · 9 mos, Hyderabad, Telangana, India, • Leading team and engaged with multiple stakeholders to ensure successful client delivery. • Coached and mentored the team members on IT Quality concepts. • Drafting planning documents and final reports for GxP projects. • Revamped and standardized the client project status reports for workforce optimization using MS-Excel and SharePoint. • Hands on experience with deliverables approvals in Asset Management, ServiceNow and JIRA. • Experience in working in tools such as Jira, Veeva Vault, HP ALM, Asset Management, Qtest, ServiceNow. • Authored on system validation deliverables like Compliance Analysis, Compliance plan, Compliance summary report. • QA/QC review of end to end SDLC documentation including User stories, Change Control documents, test plan & report, Trace Matrix. • Expertise in Functional, Regression, Integration, User Acceptance Testing and Defect Management Life Cycle. • Conducted KT (Knowledge Transfer) sessions and boot camps for the newly hired members, and Training them on multiple projects.

Solution Delivery Associate at Deloitte USI, May 2021 - May 2023 · 2 yrs 1 mo, Bengaluru, Karnataka, India, • Authored end to end SDLC deliverables for retrospective validation including Plan, User Stories, Risk Assessment, Scripts, Traceability Matrix, Report. • Conducted and facilitated manual testing (usability, functional, user, and regression) using Jira tool. • Training new team members on SDLC practice, QCSV review and different validation tools used. • Actively involved in project Kick off calls and status calls to clients. • Interacting with Business and Technical Owners and helping them for review/approval of the documents.

Solution delivery analyst at Deloitte USI, Jun 2019 - May 2021 · 2 yrs, Bengaluru, Karnataka, * Performed end to end testing of lifecycle management product. * Review of end to end SDLC documentation. * QC Review of Change Requests (RFC’s) and Design Verification Plan. * Approval of SDLC deliverables to ensure that procedures and methodologies are followed and that appropriate and complete documentation is captured and reported to support SDLC. * Practical working Knowledge of tools like SharePoint, MS-Excel (Advanced). * Client Management – Interacting with Client on a daily basis to ensure seamless delivery and escalating any risks/issues to the leadership.

Vocational trainee at Bhilai Steel Plant, SAIL, May 2017 - Jun 2017 · 2 mos

Education

Executive MBA, Business Administration and Management, General, Indian Institute of Management, Calcutta

Bachelor's degree, Electrical and Electronics Engineering, Kalinga Institute of Industrial Technology, Bhubaneswar