BINGI GANESH
Computer System Validation
Warangal
Summary
The potential knowledge gained from my previous experience would be applied effectively to your Organization. Seeking to be a well-rounded employee who would add value to your Organization.
Overview
3
3
Languages
5
5
years of professional experience
Work History
Senior Research Chemist Computer Validation System
Sai Life Sciences
10.2025 - Current
- Possess over 5 years of experience in computer system validation within pharmaceutical industry.
- Expertise in Computer System Validation and implementation of validation requirements meeting the regulatory policies within the GxP regulated environment. Software testing and in-depth understanding of SDLC processes and QMS activities.
- Presently working in Sai life sciences private limited Hyderabad in CSV.
Research Associate-II
Hetero Labs Limited
02.2022 - 10.2025
- Responsible of All Administration Activities for Manufacturing Equipment’s, CSV, and GxP System’s Classification of system based on GAMP 5 and Risk based approach to compliant GxP computerized system.
- Performing validation like GAP Assessments, Risk Assessment, GxP Assessment, OQ Test script EDC (Electronic data compliance based on 21 CFR part II & EU Annexure 1).
- Ability to execute Change control, System Classification/Software categorization/ Software sub categorization, System Criticality Assessment, ER-ES readiness, System URS, FS, DQ, Validation Plan, IO, OQ, PQ and Final ER-ES, Risk Assessment Closure, Required Traceability Matrix (RTM), Validation Summary Report (VSR) System Release Certificate.
- Preparation of validation strategy, specification documents, risk assessment, test protocols and validation report.
- Responsible for Periodic review categorization, Audit trail review, Privileges matrix, User Management, Updating Policy groups, Windows control, manual/auto backups.
- Worked on Incidents, Risk Assessment, Investigations, Root Cause Analysis, CAPA, Gap Analysis, SOP, Computerized system inventory.
- Responsible for Recipe Creations and Review.
- Responsible review of Data flow required parameters of GxP system.
- Preparation & Review of Installation Qualification (IQ) Operation Qualification document (OQ) & Performance Qualification (PQ) Protocols.
- Review of Unit & Integration Testing Documentation.
- Performed Periodic review for the validated system to determine re-qualification requirement.
- Coordinate with the business/IT teams on the pre-audit documentation and facilitate internal/external audits.
Education
Bachelor of Pharmacy -
Nethaji Institute
Hanamkonda, India 04.2001 -
Intermediate -
SPR Jr. College
Hanamkonda, India03-2016
SSC -
ZPPSS High School
Warangal, India07-2014
Skills
- Experience in validation practices with good knowledge on 21 CFR Part II, EU Annex II and GAMP 5 Guidelines and GxP (GMP,GDP, GCP, GLP) Standards
- Good knowledge on Risk based approach to GxP Computerized systems
- Preparation, Review and Execution of SDLC documents as per based on GAMP5 Guidelines (Validation Plan, User Requirement Specification, Design Qualification (DQ), Risk Assessment (RA), IQ, OQ, Traceability Matrix (TM), Compliance Report (CR), &Validation Report(VR)
- Checking the Functions like Audit trail, Print report, Alarms and Data Integrity based on 21CFR part II, GAMP5 and cGMP Guidelines
- Conduct risk assessment and determine revalidation or qualification needs based on gap analysis
- To maintain a good working environment and discipline among the team members
- Computer System Validation
- 21 CFR Part II,Data Integrity, GxP,Validation Plan, IQ, OQ, PQ, Validation Summary Reports, Traceability Matrix,SOPs,Document Management system, CAPA
- SDLC
- Agile, Watefall, V-Model
- Business Tools
- MS Office(Word, Excel, PowerPoint)
- Life Sciences Technology Products
- Track wise
PERSONAL DETAILS
- Date of birth: 16-01-19998
- Fathers name: B.kommalu
- Address: 1-49 Perumandla gudem Inavole Hanmakonda Warangal, 506310
DECLARATION:
I hereby declare that the information furnished above is true to the best of my knowledge and belief. Name: B.Ganesh
Timeline
Senior Research Chemist Computer Validation System
Sai Life Sciences
10.2025 - Current
Research Associate-II
Hetero Labs Limited
02.2022 - 10.2025
Bachelor of Pharmacy -
Nethaji Institute
04.2001 -
Intermediate -
SPR Jr. College
SSC -
ZPPSS High School