Summary
Overview
Work History
Education
Skills
Languages
Affiliations
Accomplishments
Timeline
Generic
Suhas S Udupa

Suhas S Udupa

Bengaluru

Summary

Senior Business Architecture Analyst with more than 6+ years of experience in IT Compliance and Quality Assurance for the Life Sciences industry, currently in the role of Business Architecture Senior Analyst for Accenture Life Sciences, India. successfully supported and facilitated multiple regulated software solutions for large drug manufacturing and R&D companies like USV, Lupin, Biocon, Astellas, NovoNordisk to name a few and also have experience in testing for Heavy Machinery industry solutions.

I have hands on experience in authoring validation deliverables and knowledge of various QMS tools and processes, have supported and led multiple validation, corporate audits and conducted periodic review.

Have Hands on experience in setting up & building Quality Management System, defining process, End to End Validation, training personnel on LS industry requirements.

Overview

7
7
years of professional experience

Work History

Sr. Business Analyst

Accenture
Bengaluru
02.2021 - Current

Accenture – Senior Compliance Analyst , Offshore, Operation and Maintenance Project (2023-2024)

· Supported O&M reporting activities and Authored User Review Report and Periodic Evaluation reports across different regions.

· Reported challenges part of the process and provided resolution to streamline and mitigate issues.

· I was part of the automation project team (Continuous Solution Monitoring) as a core product member involved in improving and releasing the solution as per industry best standards and end user requirements.

Accenture – Senior Compliance Analyst, Offshore, Veeva CRM Consolidation Project (2022 – 2023)

· Supported and reviewed cloud and SAP S/4 HANA solutions validation project for global roll out.

· Conducted GxP Classroom training for new joiners and training sessions on latest pharma trends and importance of process adherence and compliance requirements.

· Authored & Reviewed CSV deliverables like MVP, Project Plan, Regulatory Assessment and system categorization, BPD, URS, FRS, Risk Assessment, Design specification, VP, TP, TM, IQ, OQ, PQ, TSR, Periodic Evaluation Report, VSR, Decommissioning Plan/Report.

· Provided guidance on Risk assessments and organizational process for various project activities.

· Mitigation and resolution of defects / anomalies found during testing phase and deviation handling as per client process and QA.

· Supported the data migration activities and in defining rules for data migration verification and documentation of data migration report for various region part of the project.

Accenture – Compliance Analyst Offshore, Business As usual – EMEA Project (2021-2022)

· Drive weekly status meeting and discuss compliance issues and challenges with stakeholders.

· Reviewed and updated CAPA/Deviation/Justification report for major deviations and incidents.

· Supported and involved in process improvement for Harmonization of CSV.

Business Associate

Future Focus on Assignment to TCS
Bengaluru
04.2019 - 01.2021
  • Supported automation web development project for Heavy Machinery Industry involving :-· Invoicing, report generation, currency conversion, logistic tracking different levels of review and approval of a quotation based on regions.
  • Tested the solution as per end user requirement and expectation.
  • Conducted Demo and weekly meetings with end users to ensure efficient and expected solution delivery.
  • Responded promptly to customer inquiries and complaints.
  • Evaluated customer feedback and provided recommendations for improvement.
  • Developed and maintained customer relations by providing prompt, courteous service.
  • Participated in strategic planning meetings with senior management.

Validation Associate

IVY Works
Bengaluru
01.2018 - 03.2019

•Involved in setting up validation activities and CSV process for 100 + Equipments.

•Authored and ensured approvals for all the GxP / CSV lifecycle deliverables.

•Ensured timely and accurate business delivery is followed.

Education

Bachelor of Engineering - Computer Engineering

Global Academy of Technology
Bengaluru
07-2017

2nd PUC - Science Education

Vijaya Composite Pre University College
Bengaluru
02-2013

SSLC - High School

Vijaya High School
Bengaluru
03-2011

Skills

  • Product Management
  • Strategic Planning
  • Quality Assurance
  • Requirements Gathering
  • Agile Methodology
  • GAMP
  • 21 CFR Part 11
  • Regulatory compliance & Governance
  • Test and Release Management

Languages

English
First Language
Hindi
Advanced (C1)
C1
kannada
Proficient (C2)
C2
Telugu
Upper Intermediate (B2)
B2

Affiliations

  • Playing Cricket, Watching Movies, Trekking,

Accomplishments

  • · Member of NGO “walk free” where it up held the principle of abolishing child labor and aims to educate children through acts.

Timeline

Sr. Business Analyst

Accenture
02.2021 - Current

Business Associate

Future Focus on Assignment to TCS
04.2019 - 01.2021

Validation Associate

IVY Works
01.2018 - 03.2019

Bachelor of Engineering - Computer Engineering

Global Academy of Technology

2nd PUC - Science Education

Vijaya Composite Pre University College

SSLC - High School

Vijaya High School
Suhas S Udupa