Gaddam Bhaskara Rao
IT GxP Consultant | Computer System Validation | Pharma IT Specialist
Your next IT GxP hire — zero critical audit findings across 13 years in pharma.
Specialised in Computer System Validation, LIMS/CDS administration, and Digital Transformation across API, OSD, CDMO, and Life Sciences environments.
+91 96520 21788 — Call Now
Bridging Compliance & Technology in Pharma
IT GxP professional with 13+ years of experience building audit-ready systems across Computer System Validation (CSV), LIMS/ELN administration, Serialization & Track & Trace, Data Integrity, and Digital Transformation — spanning API, OSD, CDMO, and Life Sciences environments.
Delivered zero critical audit observations across USFDA, MHRA, and WHO inspections. Expert in implementing and validating regulated systems aligned with 21 CFR Part 11, Annex 11, GAMP 5, and ALCOA+ Data Integrity principles — from URS through PQ, Go-Live, and periodic review.
Career Progression
Core Competencies
Technical Competencies
Regulatory Frameworks
Regulatory Audit Support
Domain Coverage
Professional Experience
13+ years of progressive growth across pharmaceutical and life sciences organizations.
Business Consultant – IT GxP (CSV & Application Implementation)
VRR Life Science Services LLP
Client: Ritsa Pharma Pvt. Ltd., Hyderabad
- ▸Leading CSV and implementation of manufacturing and laboratory systems including Empower 3.8.1, LabSolutions UV-Vis, Tiamo, Track & Trace CRM, and backup solutions.
- ▸Ensuring validated and compliant data flow between manufacturing equipment (V-Blender, RMG, FBD, Compression, Coating, Counting machines) and SCADA systems.
- ▸Executing full system qualification lifecycle activities (URS to PQ and Go-Live) while maintaining audit-ready documentation.
- ▸Developing SOPs, managing change controls and periodic reviews, and conducting user training.
- ▸Managing user access control, email creation, software license allocation, and overall system administration.
- ▸Providing end-to-end IT infrastructure and networking support including desktop policy management, backup, restoration, and archival.
- ▸Delivering Track & Trace support including master data registration, batch planning, commissioning, aggregation, and EPCIS reporting (NS2, NS3, SBDH) with L1–L4 technical support.
Business Consultant – IT Risk, Compliance & Data Integrity
EY LLP
Hyderabad
- ▸Performed GxP gap assessments and risk evaluations for critical laboratory and business systems.
- ▸Provided audit support for Aurobindo Pharma (Units 1, 5 & 7) and Neuland Pharma (Units 1 & 2).
- ▸Supported LMS assessments and Data Integrity compliance programs aligned with global regulatory expectations.
- ▸Delivered Data Integrity compliance programs aligned with global regulatory expectations.
Assistant Manager – CSV GxP
Lab Iconics Technologies LLP
Hyderabad
- ▸Implemented CSV strategy across SCADA (Automatic Loading and Unloading System with lyophilizer), LIMS & supporting applications in pharma client environments.
- ▸Conducted end-to-end validation and testing of Lab Iconics LIMS & ELN systems.
Quality Assurance Specialist (CSV GxP)
Synthesis Solutions LLP
Bangalore
- ▸Oversaw ITQA activities, deviation handling & CAPA execution for lab systems; SOP preparation.
- ▸Handled clients including Biocon, Accord Pharma, Lupin, Granules India, Sun Pharma on LabWare LIMS, Caliber eLIMS, and Sample Manager LIMS.
Sr. Validation Engineer – CSV
Artech Infosystems (Lupin Limited)
Goa
- ▸Performed system validation for GxP applications, ensuring compliance with 21 CFR Part 11.
- ▸Served as Senior Validation Engineer for pharmaceutical and biotech plant operations.
- ▸Handled Packing, Manufacturing Equipment & Quality Systems: eLog, SABA LMS, LIMS, etc.
Quality Officer – GxP (IT)
Natco Pharma Ltd.
Hyderabad
- ▸Managed Caliber eLIMS as SME and System Administrator.
- ▸Conducted master data configuration, user management, training, and audit readiness activities.
- ▸Administered Empower CDS, system backups, and QC IT applications.
Sr. Assistant – QC (IT)
Aurobindo Pharma Ltd.
Hyderabad
- ▸Supported ERP and eLIMS deployment, ensuring data accuracy, integrity, and compliance with quality standards.
- ▸Prepared Certificates of Analysis (CoA) in ERP and coordinated with QA for review and approval.
- ▸Led the raw material sampling team, managing allocations and overseeing sample distribution and tracking.
- ▸Handled Empower administration, license management, and related QC IT activities.
Quality Analyst (IT GxP) – eLIMS & Empower
Divis Laboratories Ltd.
Hyderabad
- ▸Performed Empower administration, system qualification, and documentation control in compliance with GxP requirements.
- ▸Supported implementation and POC activities for Caliber eLIMS, QAMS, DMS, LMS, COA release systems, Tiamo, and Malvern applications.
- ▸Contributed to API product release processes through EasyLabel software and label design configuration.
System Expertise
Hands-on experience implementing, validating, and administering regulated systems across the pharma lifecycle.
Laboratory Systems (LIMS/ELN)
Chromatography Data Systems (CDS)
Serialization & Track & Trace
Manufacturing & SCADA
Enterprise & Quality Systems
IT Infrastructure
Key Achievements
Measurable outcomes delivered across 13+ years in pharmaceutical IT compliance.
Zero Critical Audit Observations
Delivered multiple validated implementations with zero critical audit findings across USFDA, WHO, and MHRA inspections.
40% Reduction in Manual Operations
Reduced manual operations by 40% through targeted digital transformation initiatives in regulated pharmaceutical environments.
Secure GxP Infrastructure
Implemented secure, validated server infrastructure for GxP systems compliant with 21 CFR Part 11 and Annex 11 requirements.
Data Integrity Remediation
Executed comprehensive Data Integrity assessments and remediation programs aligned with ALCOA+ principles and global regulatory expectations.
End-to-End Serialization Compliance
Enabled seamless serialization and EPCIS reporting for packaging lines, including SSCC, GTIN, and aggregation processes.
Multi-Client Regulatory Support
Provided direct audit support for USFDA, MHRA, and WHO inspections across major pharmaceutical companies including Aurobindo, Lupin, Biocon, and Neuland.
Education
Master of Science (Chemistry)
CDE, Acharya Nagarjuna University
Guntur, Andhra Pradesh, India
Bachelor of Science (MPC)
Jagarlamudi Kuppuswamy Choudary College
Affiliated by Acharya Nagarjuna University, Guntur
Intermediate
Sai Sadana MMP Jr. College
Guntur, Andhra Pradesh, India
SSC
Naveena Vidhyanikethan High School
Guntur, Andhra Pradesh, India
Certifications
Formally certified in regulated systems and technologies core to pharmaceutical IT compliance.
Caliber eLIMS
Caliber Technologies
LIMS Administration
Empower 3 CDS
Pharma Palashala
Chromatography Data System
SQL Server T-SQL
SQL School
Database & Query Language
Trainings Delivered
Conducted hands-on user training across regulated pharma systems for QC, QA, and IT teams.
Contact
Available for IT GxP consulting, CSV projects, and digital transformation engagements.
I am open to full-time, contract, and consulting engagements in IT GxP, CSV, LIMS implementation, and pharmaceutical digital transformation.