Computer System Validation • Life Sciences

Srinivas Kondeti

Senior Computer System Validation Professional

CSV / CSA professional with 8+ years of experience delivering compliant computerized system implementations, validation programs, and production support within regulated pharmaceutical and life sciences environments.

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8+ Years Experience
35+ Implementations
Global US • UK • Asia
GxP Regulated Systems
Srinivas Kondeti
CSV / CSA Life Sciences Professional
About Me

Validation expertise built in regulated environments.

I bring more than eight years of professional experience in computer system validation, software implementation, project delivery, and production support, primarily within regulated pharmaceutical and life sciences environments.

My experience includes Quality Management Systems, Document Management Systems, Laboratory Information Management Systems, and Training Management Systems.

My work spans requirements, functional specifications, risk assessment, IQ/OQ/PQ, UAT/SAT, traceability, validation reporting, change control, deviations, CAPA, audit readiness, and production support.

I have supported global cross-functional teams across the United States, United Kingdom, and Asia, working closely with QA, business users, technical teams, and vendors.

▣
8+
Years of experience
✓
35+
System implementations
◎
GxP
Compliance focused
◌
Global
US • UK • Asia
Core Expertise

CSV / CSA expertise across the system lifecycle.

Practical experience supporting validation, software assurance, risk-based testing, quality processes, and continued system compliance.

CSV

Computer System Validation

Validation planning, requirements, specifications, traceability, protocols, testing, and summary reporting.

CSA

Computer Software Assurance

Risk-based assurance aligned to intended use, patient safety, product quality, and critical functionality.

QUALITY

Compliance & Quality Systems

Change control, deviations, CAPA, audit readiness, data integrity, electronic signatures, and audit trails.

DELIVERY

Implementation & Support

Configuration, UAT/SAT, training, deployment, stakeholder coordination, and post-go-live production support.

Experience

Professional Experience

Progressive experience across validation, product consulting, implementation, quality systems, and regulated software support.

Jan 2022 – Aug 2023

Senior Product Specialist

Caliber Technologies Pvt. Ltd.
  • Led and supported computerized system implementations in regulated pharmaceutical environments.
  • Coordinated with QA, business, technical, and vendor teams across validation and deployment activities.
  • Supported global projects across the United States, United Kingdom, and Asia.
  • Managed validation, configuration, UAT/SAT, deployment, and post-go-live support activities.
Earlier Roles

Product Consultant / Senior Product Consultant

Caliber Technologies Pvt. Ltd.
  • Supported requirements gathering, system configuration, validation testing, and user training.
  • Prepared and executed IQ, OQ, PQ, UAT, traceability, and validation documentation.
  • Supported deviation investigation, change management, and production issues.
Career Start

Validation Engineer

Caliber Technologies Pvt. Ltd.
  • Prepared validation plans, URS, functional specifications, risk assessments, and traceability documentation.
  • Executed validation protocols and documented objective evidence.
  • Supported compliant system implementation and release activities.
Systems & Compliance

Regulated enterprise systems and frameworks.

Experience across quality, document, laboratory, and training management systems, supported by recognized regulatory and validation practices.

eQMS

Quality Management Systems

CAPA, change control, deviations, workflows, approvals, and quality processes.

EDMS

Document Management Systems

Controlled documents, approvals, periodic review, and document lifecycle management.

LIMS

Laboratory Information Management

Computerized laboratory workflows supporting regulated quality environments.

TMS

Training Management Systems

Training assignments, qualification, compliance tracking, and employee learning processes.

GAMP 5 21 CFR Part 11 EU Annex 11 GxP CSV CSA Risk Assessment Data Integrity Electronic Signatures Audit Trails Change Control CAPA Deviation Management Audit Readiness
Validation Lifecycle

End-to-end CSV lifecycle.

From planning and requirements through validation reporting, go-live, and continued compliance.

01 Validation Plan
02 URS
03 Risk Assessment
04 FS / Configuration
05 IQ
06 OQ
07 PQ / UAT
08 Traceability
09 Validation Report
10 Go-Live
Global Experience

Supporting teams across regions.

🇺🇸

United States

Pharmaceutical system implementation, validation, production support, and stakeholder collaboration.

🇬🇧

United Kingdom

On-site implementation, validation, system testing, training, and stakeholder coordination.

🌏

Asia & International

Multi-site computerized system implementations and regulated software deployment support.

Let's Connect

Open to CSV / CSA opportunities.

Interested in Computer System Validation, Computer Software Assurance, Quality Systems, and regulated computerized system opportunities within pharmaceutical and life sciences organizations.

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