
Srinivas Nagula
Quality Control Chemist Formulations

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Skills
21 CFRAnalytical SkillsAudit CompliancesChange ControlChange ManagementChromatographyComputer System ValidationCorrective and Preventive Action (CAPA)Data ManagementDefect Life CycleGAMP CategorizationGap AnalysisGood Laboratory Practice (GLP)Governance, Risk Management, and Compliance (GRC)GxPHigh-Performance Liquid Chromatography (HPLC)IQ,OQ,PQLIMSRisk ManagementRoot Cause AnalysisSoftware Development Life Cycle (SDLC)SpectroscopyTest PlanningTest ProtocolsTraceability MatrixU.S. Food and Drug Administration (FDA)V-ModelAbout me
βYou Canβt Improve what you donβt measure β-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 π π―ππππ, π° ππ Srinivas Nagula ππππ & ππππππ ππ Godavarikhani, Telangana, πππππππππ πππππππ ππ 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 peopleβs 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: π 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: π 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. π€ 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 - 2009Master's degree Organic Chemistry 7.5
Kakatiya University
2004 - 2007Bachelors Degree Botany, Biotech, Chemistry
Little Flower High School
1999 - 2000S S C Schooling Grade A
ICFAI University
2020 - 2022MBA(Pharma Management) pharma Management
Experience

AUROBINDO PHARMA LTD
May 2010 - Jan 2015Quality Control Chemist FormulationsRaw 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 2016Quality Control Officer in PharmaceuticalsTesting 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 2024Computer System Validation in Life Science ProjectsCSV 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 - nowApplication Manager
Licenses & Certifications

Basics of Testing
Linkedin LearningNov 2023
IT Risk Assesment
Linkedin LearningNov 2023
E signature in pharma Challenges, solutions and best practices
QualisteryMar 2023
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