UPPUTURU GEETHANJALI
Kurnool
Summary
Dynamic Senior Associate with extensive experience in Computer System Validation at One Source, excelling in GxP compliance and risk management using FMEA. Proven track record in managing change controls and CAPA, ensuring data integrity and adherence to 21 CFR Part 11. Passionate about driving quality and continuous improvement in validation processes.
Overview
11
11
years of professional experience
Work History
Senior associate - Computer System Validation (CSV)
One Source
Bengaluru
09.2021 - Current
- Hands-on experience in the preparation of validation deliverables like User Requirements Specification, Validation (VP) plan, Configuration Specification (CS), Functional Specification (FS), Infrastructure Qualification Document (INQD), Installation Qualification Document (IQD), Operation Qualification Document (OQD), Performance Qualification Document (PQD), Traceability Matrix Report (TMR), and Project Validation Report (PVR).
- The review of the high-level risk assessment includes GxP assessment, GAMP categorization, criticality assessment, ERES applicability assessment, etc.
- Hands-on experience in performing initial system assessment for applications, which includes GxP assessment, cloud assessment, and GAMP categorization.
- Hands-on experience in performing Functional Risk Assessment (FRA) using FMEA.
- Preparation of periodic review protocols, execution of the protocols, and preparation of periodic review reports.
- Handling of change controls, deviations, incidents, and CAPA in TrackWise.
- Ongoing project - Product Lifecycle Management (PLM) - In-premise to cloud migration and software upgradation.
- Computer system validation of LabWare LIMS software.
- Hands-on experience in performing the validation using the SDLC V model, and I have theoretical knowledge of the Waterfall model and Agile methodology.
- Enterprise applications handled include: Laboratory Information Management System (LIMS), TrackWise (QMS), Learning Management System (LMS), Veeva Vault - QualityDocs, and Validation Life Cycle Management System (eVLMS).
- Software operating equipment: Rudolph PC Interface, Lab Solutions, Tiamo, Spectrum ES.
Executive
Strides Pharma Science Limited
Bengaluru
02.2019 - 08.2021
- Hands-on experience in handling Change Controls, Deviations, and CAPA.
- Hands-on experience in the preparation of periodic review protocols and in performing the periodic review for Empower3, Tiamo, Lab Solutions, Chromeleon, and Perkin Elmer.
- Hands-on experience preparing protocols, specifications, SOPs, standard testing procedures, and stability trends.
- Raw material, finished product, stability products analysis.
Officer
Medreich Limited
Bengaluru
01.2015 - 01.2019
- Hands-on experience in handling change controls, deviations, incidents, and CAPA.
- Hands-on experience in the review of protocols, analytical data, specifications, SOPs, and other related quality documents.
- Preparation of specifications and STPs as per the pharmacopeias.
- Raw material, FP, FG, and PM analysis.
Education
Master of Pharmacy -
Sri Krishna Chaitanya College of Pharmacy
Madanapalle, Andhra Pradesh.05-2013
Bachelor of Pharmacy -
Fatima Institute of Medical Sciences.
Kadapa, Andhra Pradesh06-2011
Skills
- Computer system validation
- Software development life cycle (SDLC)
- Software testing life cycle (STLC)
- Good automated manufacturing practices (GAMP 5)
- Electronic validation life cycle management system (eVLMS)
- Change controls
- Deviations
- Incidents
- CAPA
- Risk management using FMEA
- Periodic review
- 21 CFR Part 11 and EU Annex 11
- Data integrity
- Gxp compliance
- ALCOA
- Business continuity
- Disaster recovery
- Smoke testing
- Sanity testing
- Regression testing
- White box testing
- Black box testing
- Positive testing
- Negative testing
- Trackwise
- SAP
Timeline
Senior associate - Computer System Validation (CSV)
One Source
09.2021 - Current
Executive
Strides Pharma Science Limited
02.2019 - 08.2021
Officer
Medreich Limited
01.2015 - 01.2019
Master of Pharmacy -
Sri Krishna Chaitanya College of Pharmacy
Bachelor of Pharmacy -
Fatima Institute of Medical Sciences.