Ravikiran Nimmagadda
Hyderabad
Summary
Accomplished Senior Research Scientist with a proven track record of 12 years in AR&D Validations and 6 years on Computer System validations (CSV) leveraging expertise in SDLC processes currently looking to work in a challenging environment and contributing constructively to the growth of the organization.
Overview
12
12
years of professional experience
Work History
Sr. Research Scientist
Matrix Pharma (Formerly Viatris)
09.2017 - 10.2024
- Currently working as Sr. Research Scientist in validation Laboratory for Matrix pharma (Formerly Viatris laboratories) Hyderabad.
- Timely perform various CSV related activities for new and existing systems as per GAMP5 risk based approach and EU Annexure 11 to meet cGMP standards.
- Preparation of various requirement specifications, Initial Risk Assessments. Preparation of Validation plan.
- Prepare IQ/OQ/PQ protocols, test case design, testing / verification.
- Experience in documentation of various documents like Validation Master Plans (VMP), Installation Qualifications (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirement Traceability Matrix (RTM), Incident reports if any, CAPA's and Validation Summary Reports (VSR).
- Technical review & support to Quality Risk management report (QRM) as SME for software privileges.
- Ensuring complete 21CFR Part11 compliance assessment for pharmaceutical systems.
- Well versed in software development life cycle (SDLC) process which is used for planning, creating, testing, and deploying computer system by using VModel.
- Perform and review of Elemental impurities method Validations on ICP-MS/AAS. Work allocation to junior analyst.
- Maintenance of analytical instruments, preparation of Standard Operating Procedures.
- Expertise in handling Laboratory Investigations/Deviation/Incident reports/change controls using “Trackwise software”.
Scientist
Vimta Labs
06.2016 - 09.2017
- Worked as Scientist in Trace Analysis Lab Pharma (TAL-P) “Vimta Labs Limited” Hyderabad.
- Worked as project lead for Delamination studies of packing materials conducted using analytical equipment like ICP-MS, ICP-OES, SEM, Electron microscopy & liquid particulate counter.
- Prepare User requirement specification (URS) for new system. Calibration of instruments.
- Elemental Impurities method development, Validation, Method verification by ICP-MS, AAS and ICP-OES.
- Preparation of method validation / Verification /Delamination study protocols and reports and batch reports.
- Handling of QA audits, Supporting Regulatory / client audits, customer queries response.
- Handling of Incidents/Deviations & investigations.
Associate
Choksi Labs
01.2016 - 06.2016
- Worked as Associate in Drugs and chemicals Choksi Labs Limited, Indore Madyapradesh.
- Review of raw data, test reports generated for Raw materials, Intermediate & API using AAS and ICP-MS.
- Elemental Impurities batch analysis, Validation, Method verification by ICP-MS, AAS.
Senior Analyst
Sipra Labs
01.2013 - 01.2016
- Worked as S.r Analyst in Formulation Research & Development department Sipra Labs Limited, Hyderabad.
- Elemental Impurities method development, Validation, Method verification, batch analysis as per Method of analysis using ICP-MS, AAS.
- Analysis of Raw materials, Intermediate, API products using chromatographic by HPLC.
- Prepare User requirement specification (URS) for new system, IQ, OQ & PQ for instruments. Calibration and maintenance of instruments as per schedule.
- Preparation of method validation/verification protocols & reports. Recording of analytical data online and compliance with regulations.
- “Extractable & Leachable” studies for packing material on ICP-MS.
Education
M.Pharmacy in Industrial Pharmacy
Annamalai University
Chidambaram, India08-2011
Skills
- Computer System Validation
- Knowledge on SDLC and testing techniques
- Documents handled (URS, VMP, IQ, OQ, PQ etc)
- Analytical Research & Development, Validations
- ICP-MS, AAS, ICP-OES, HPLC
- Handling Lab Investigations Deviation, Incident, change controls, CAPA using “Trackwise software”
Additional Information
Name : Ravikiran Nimmagadda
Date of birth : 28-06-1988
Sex : Male
Contact Address : D.No. 2-195, Jagannadhapuram, Gopalapuram (MDL)
East godavari (dist), Andhra Pradesh -534312.
Languages
English
Advanced (C1)
Telugu
Bilingual or Proficient (C2)
Hindi
Upper intermediate (B2)
Tamil
Upper intermediate (B2)
Software
Operating Systems : Windows 7, 10 Software : LIMS, Trackwise, D2Documentum, CARA Packages : Ms office
Declaration: I do here by declare that the particulars of information and facts stated here in above are true, correct and complete to the best of my knowledge and belief
Place : Hyderabad
Date : 19112024
Ravikiran Nimmagadda
Timeline
Sr. Research Scientist
Matrix Pharma (Formerly Viatris)
09.2017 - 10.2024
Scientist
Vimta Labs
06.2016 - 09.2017
Associate
Choksi Labs
01.2016 - 06.2016
Senior Analyst
Sipra Labs
01.2013 - 01.2016
M.Pharmacy in Industrial Pharmacy
Annamalai University
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