Srinivas Nagula

Srinivas Nagula

Quality Control Chemist Formulations

Followers of Srinivas Nagula6000 followers
location of Srinivas NagulaHyderabad, Telangana, India

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  • Timeline

  • Skills

    21 CFR
    Analytical Skills
    Audit Compliances
    Change Control
    Change Management
    Chromatography
    Computer System Validation
    Corrective and Preventive Action (CAPA)
    Data Management
    Defect Life Cycle
    GAMP Categorization
    Gap Analysis
    Good Laboratory Practice (GLP)
    Governance, Risk Management, and Compliance (GRC)
    GxP
    High-Performance Liquid Chromatography (HPLC)
    IQ,OQ,PQ
    LIMS
    Risk Management
    Root Cause Analysis
    Software Development Life Cycle (SDLC)
    Spectroscopy
    Test Planning
    Test Protocols
    Traceability Matrix
    U.S. Food and Drug Administration (FDA)
    V-Model
  • About me

    β€œYou Can’t Improve what you don’t measure β€œ-Michael Hyatt Delivering accurate & quality-oriented Computerized system validations to help IT Industry to develop life science projects by following regulatory compliances, minimize the Risk and implement strategic actions for controlled revenue growth πŸ™‹ 𝑯𝒆𝒍𝒍𝒐, 𝑰 π’‚π’Ž Srinivas Nagula 𝒃𝒐𝒓𝒏 & π’“π’‚π’Šπ’”π’†π’… π’Šπ’ Godavarikhani, Telangana, π’„π’–π’“π’“π’†π’π’•π’π’š π’˜π’π’“π’Œπ’Šπ’π’ˆ π’Šπ’ Hyderabad. Since my early phase of my life I believe good education helps to have a good settlement in life. As a child still I remember I put ointment in table spoon and heat it, I see in a few minutes it turns in to a liquid. As a child I am interested in Chemical processes followed my intuition and did my MSC in organic chemistry started my career as a Quality control in pharmaceutical formulation manufacturing unit, as a Quality control analyst I handled all the Analytical Instruments check the quality of drug products and drug substances, Regulatory compliance. During in this journey I had opportunity to work with the validation of Computer systems using GAMP, SDLC, V model, 21 CFR, EU Annexure 11 requirements in minimizing the Risk of applications. Since from my childhood I am Ambitious to grow in my life , at this point I started a Startup in Ecommerce with few of my friends , my start up failed after few months because I did not have the experience in business. As I have strong intention to help and transform people’s lives I use my writing skills and published a book recently " Beyond job life" which is available in Flipkart and Amazon as well. Testing Skills: πŸ‘‡ 1. Knowledge of SDLC and STLC. 2. Knowledge of Defect Life Cycle (Tracking) 3. Knowledge of Manual Testing 4. Experience with the test-plan documents, test case design, test scenario documents 5. GAMP Categorization 6. V Model and Agile Technologies 7. Hands on Experience with Analytical Instruments HPLC,UV, IR and many more Projects Handled: πŸ‘‡ Standalone (Mfg & QC) Systems, Server-client Systems, Enterprise Systems (DMS, LMS) QAMS (Caliber & Trackwise), Empower, Chromeleon, TIAMO2.4, Stability, Mastersizer, LabSolutions, etc. I constantly try to learn and adapt. I keep myself updated on new articles in software development and fields I'm interested in. My constant drive to learn something new is my greatest USP. πŸ“€ Connect with me at srinivas_nagula@ymail.com to know how I contribute to your organization Thank you for visiting me here

  • Education

    • Andhra University

      2007 - 2009
      Master's degree Organic Chemistry 7.5
    • Kakatiya University

      2004 - 2007
      Bachelors Degree Botany, Biotech, Chemistry
    • Little Flower High School

      1999 - 2000
      S S C Schooling Grade A
    • ICFAI University

      2020 - 2022
      MBA(Pharma Management) pharma Management
  • Experience

    • AUROBINDO PHARMA LTD

      May 2010 - Jan 2015
      Quality Control Chemist Formulations

      Raw material of both APIs and Excipients sampling and Analysis using wet chemistry and by using Analytical techniques like High pressure liquid chromatography, Ultra visible spectroscopy, Infrared spectroscopy, Titrations using Metrohm Tiamo and manual Regulatory compliance, documentation practices for regulatory requirements, Exposure of regulatory Audits like US FDA, MHRA, TGA,WHO.Transcription of data from raw data printouts to worksheets and LIMS.

    • Mylan

      Jan 2015 - Dec 2016
      Quality Control Officer in Pharmaceuticals

      Testing of Stability of Drug Products, Risk Management, 21 CFR guidelines, Quality compliances, LIMSTranscription of data from raw data printouts to worksheet and LIMS. Sample Reconciliation of Stability samples and raw materials .

    • Jodas Expoim Pvt. Ltd.

      Dec 2016 - Jan 2024
      Computer System Validation in Life Science Projects

      CSV Compliance review, and or approval of Qualification/validation documents(URS,DQ,IQ,OQ,PQ, RTM, Risk Assessments. Involving other all quality-related activities (Deviations and CAPA ), regulatory Audits and Internal Audits, Familiar with compliance requirements (FDA, EMA, GMP,GLP, 21 CFR GAMP, Disaster Recovery)

    • Cognizant

      Feb 2024 - now
      Application Manager
  • Licenses & Certifications

    • Basics of Testing

      Linkedin Learning
      Nov 2023
    • IT Risk Assesment

      Linkedin Learning
      Nov 2023
    • E signature in pharma Challenges, solutions and best practices

      Qualistery
      Mar 2023