Loading profile…
Loading profile…
Quality Assurance Analyst
Quality Assurance Analyst at Clario managing TrackWise Digital quality events and CAPAs across clinical and enterprise operations.
United StatesQuality Assurance Analyst at Clario
Manage and investigate Quality Events and Deviations using Salesforce Enterprise Quality Management System (eQMS)-Trackwise Digital. Collaborate with cross-functional teams to drive timely resolution of quality issues and ensure compliance.
TrackWise QMSCAPA ManagementDeviation ManagementChange ControlRoot Cause AnalysisRisk ManagementValidation DocumentationRegulatory ComplianceSalesforceQuality MetricsDashboarding
Managed QMS responsibilities including Deviations, CAPAs, and Change Controls for Metered Dose Inhalers. Prepared and revised SOPs, batch packaging records, and ensured ALCOA++ compliance.
TrackWise QMSCAPA ManagementDeviation ManagementChange ControlRoot Cause AnalysisFMEAImpact AssessmentsALCOA+ StandardsMaster Control SystemSOP DevelopmentBatch Packaging Records
Maintained and tracked change control documents, managed document workflows in ENSUR, and handled audit management. Supported CAPAs, NCRs, Deviations, and investigations.
ENSUREQMS AdministrationChange ControlDocument ManagementAudit ManagementCAPANCRDeviationsInvestigationTraining MatricesLMSTest ScriptsValidationDocument MigrationLIMSCrystal Reports
Created and approved analytical lab documents, stability study SOPs, and finished product certificates of analysis. Worked with QA for approval of quality control documents.
Document ManagementSOP DevelopmentStability StudiesCertificate Of AnalysisLIMSCrystal ReportsPaper Based Data Management Systems
Worked in quality control and quality assurance departments, handling analytical equipment and acquiring knowledge on product formulation and storage procedures.
HPLCAnalytical ToolsGood Documentation Practices (GDP)SOP preparation
Completed FDA/NIH webinar on Regulatory Do's and Don'ts, covering regulatory resources and early engagement programs.
Completed SharePoint Administration training, covering site architecture, user management, and security features.
Completed Quality Management Foundations training, covering quality frameworks, continuous improvement, and ISO 9001 principles.
Completed Quality Management Foundations training, covering quality frameworks, continuous improvement, and ISO 9001 principles.
Completed Smartsheet Essential Training, covering sheet creation, sharing, dashboards, and formula creation.
Completed Root Cause Analysis eLearning course, covering 5M's, 5Y's, Pareto Analysis, and Fishbone Analysis.
Completed FDA webinar on Electronic Drug Registration and Listing (eDRLS), covering NDC format and submission requirements.
Completed QMS Bootcamp covering QMS building blocks, SOPs, role-based training, and quality events.
Completed Certificate Course in Signal Detection and Management in Pharmacovigilance, covering signal detection and assessment.
Completed Certificate Course in Pharmacovigilance ICSR Case Processing, covering drug safety and case processing.
Master's Degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, Boston, MA, from 2013 to 2015.
Master's Degree in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University, Boston, MA, from 2013 to 2015.
Completed NIH web-based training on protecting human research participants.
Master's Degree in Pharmacy with a focus on Pharmacology from Lalitha College of Pharmacy, India, from 2010 to 2012.
Master's Degree in Pharmacy with a focus on Pharmacology from Lalitha College of Pharmacy, India, from 2010 to 2012.
Bachelor's Degree in Pharmacy from SHADAN College of Pharmacy, India, from 2006 to 2010.
Bachelor's Degree in Pharmacy from SHADAN College of Pharmacy, India, from 2006 to 2010.
Profile sourced from Himalayas.