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GopalaKrishnan Kuseladoss

@gopalakrishnankusela

Project Quality Manager at HCL Technologies who oversaw GxP implementations and migrations for Sandoz across Salesforce, Veeva, and MES.

India
Message

At HCL Technologies, I provided Project Quality Management for Sandoz, overseeing system implementations and migrations involving Salesforce, Veeva, MES, and other GxP applications. I prepared validation documentation and reviewed key qualification deliverables to support regulatory compliance.

At Saama Technologies, I served as Offshore Head for the Quality Management Office, supporting customer audits and executing internal quality audits. I coordinated CAPAs and vendor assessments, and authored or updated system documentation and procedures.

Across roles with RxLogix Corporation India Pvt. Ltd., Infosys Business Consulting, HCL Technologies, and iGATE Global Solutions, I worked on GxP validation, quality management, and IT infrastructure qualification. My work included validation planning and reporting, audits, change control, and qualification of server and database environments.

Experience

Work history, roles, and key accomplishments

HCL Technologies logoHT

Senior Consultant

Mar 2024 - Jun 2026 (2 years 3 months)

Provided project quality management services to a European pharmaceutical client, ensuring regulatory compliance and strategic quality oversight for system implementations and migrations. Led validation documentation, reviews, and CAPA implementation.

CSV
CSA
GxP ComplianceQMS
Validation Lifecycle Management
IQ OQ PQ Validation
21 CFR Part 11
SalesforceVeevaMESChange ControlCAPAAuditRFQ
Saama Technologies logoST

QMO Manager

Saama Technologies

Dec 2022 - Dec 2023 (1 year)

Served as Offshore Head for Quality Management Office, supporting customer audits, executing internal quality audits, and coordinating CAPA. Authored system documentation and led vendor assessments.

iGATE Global Solutions logoIS

Technical Lead - Validation Manager

iGATE Global Solutions

May 2010 - Apr 2014 (3 years 11 months)

Defined and reviewed validation checklists and deliverables for GxP projects, authored validation plans and summary reports, and approved key validation documents.

Validation Plan Authoring
URS SRS SDS
IQ OQ PQ Validation
RTM
Test Execution
Validation Summary Reports

Education

Degrees, certifications, and relevant coursework

Madras Christian College logoMC

Madras Christian College

Master of Science, Mathematics

Master of Science in Mathematics from Madras Christian College, affiliated with the University of Madras.

Tech stack

Software and tools used professionally

Availability

Looking for a job

Location

India

Authorized to work in

Salary expectations

210k+ INR

Job categories

Project Quality Manager
Quality Manager
Validation Manager
Compliance Manager

Skills

Computer System Validation (CSV)
Computer System Assurance (CSA)
GxP Compliance
Project Quality Management
Infrastructure Qualification
Quality Management Systems
Validation Lifecycle Management
21 CFR Part 11
EU GMP Annex 11
GAMP 5 Best Practices
ALCOA+ Data Integrity
Validation Plan Authoring
Requirement TraceabilityRisk AssessmentFMEA

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