# GopalaKrishnan Kuseladoss

GopalaKrishnan Kuseladoss is a remote worker on Himalayas, Senior Consultant at HCL Technologies, based in India.

Source: https://himalayas.app/@gopalakrishnankusela

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

| Detail | Value |
| --- | --- |
| Availability | Looking for a job |
| Location | India |
| Authorized to work in | India |
| 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 Traceability, Risk Assessment, FMEA |

## About

```text
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

### Senior Consultant

[HCL Technologies](https://himalayas.app/companies/hcltech). Mar 2024 - Jun 2026

```text
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.
```

Skills: CSV, CSA, GxP-Compliance, QMS, Validation-Lifecycle-Management, IQ-OQ-PQ-Validation, 21-CFR-Part-11, Salesforce, Veeva, MES, Change-Control, CAPA, Audit, RFQ

### QMO Manager

Saama Technologies. Dec 2022 - Dec 2023

```text
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.
```

Skills: QMS, Audit, CAPA, Vendor-Assessment, Documentation, RFP, Software-Validation

### Quality Lead

[RxLogix Corporation India Pvt. Ltd.](https://himalayas.app/companies/rxlogix). Apr 2021 - Nov 2022

```text
Provided CSV expertise for GxP drug safety products across the validation lifecycle, reviewed key deliverables, and validated QMS tools. Guided change control and performed internal audits.
```

Skills: CSV, Pharmacovigilance, Validation-Lifecycle-Management, QMS, ZenQMS, Change-Control, Audit, SOPs

### Consultant - Project Quality Manager

[Infosys Business Consulting](https://himalayas.app/companies/infosys-limited). Aug 2019 - Apr 2021

```text
Managed quality and compliance for multiple GxP projects, prepared validation plans, and ensured traceability. Coordinated testing, change management, and supported audits and inspections.
```

Skills: GxP-Compliance, Validation-Study-Plans, Traceability, Change-Management, Audit, Inspections, Qualification-Reports

### Manager - Quality & Compliance Lead

[HCL Technologies](https://himalayas.app/companies/hcltech). Apr 2014 - Aug 2019

```text
Handled offshore team, reviewed project documentation, executed IT infrastructure qualifications, and performed monthly GxP audits. Drove deviation management and monitored security compliance.
```

Skills: Infrastructure-Qualification, GxP-Auditing, Deviation-Management, Document-Management, Training, Security-Compliance

### Technical Lead - Validation Manager

iGATE Global Solutions. May 2010 - Apr 2014

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

Skills: Validation-Plan-Authoring, URS-SRS-SDS, IQ-OQ-PQ-Validation, RTM, Test-Execution, Validation-Summary-Reports

## Education

### Madras Christian College

Master of Science, Mathematics

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

## Tech stack

- Salesforce
- Veeva
- Jira
- Confluence
- ServiceNow

To contact GopalaKrishnan, message them from this profile with a Himalayas employer account: [Hire on Himalayas](https://himalayas.app/hire).

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