Giridhar Danda
Sr executive in Quality Assurance, Aurobindo pharma
- Role
- Sr Executive at Aurobindo Pharma Ltd
- Location
- Hyderabad, TG, IN
- LinkedIn followers
- 500 followers
About Giridhar Danda
Sound knowledge of FDA & EMA Guidelines, CSV, CSA, GAMP 5, GxP, QMS Process in GxP Software Development and Validation.Knowledge of all SDLCmodels for GxP Software Development.(Waterfall, V & Agile)Core Understanding of Validation of GxP & SaMDApplications.Well versed with Scripted Testing and Unscripted Testingfor Risk based Approach of Validation.Significant exposure in maintaining & ensuring stringentadherence to GO guidelines.Effectivehandling of Risk assessment on process gaps and potential riskalong with implementation ofremedial action plans through Risk methodology (FMEA).Expertise in Drafting and Reviewing of Validation Plan, Requirement Traceability Matrix, Test plans, Test Scripts & Validation Summary Report.Drafting, Reviewing and Executionof Test cases based on functional & GxP requirements from URS/PRS/ SRS.Implementation of 21 CFR Part 11;Data Integrity and GxP regulations.Effective handling of Non-conformance occurred during Validation & GxP audits.Conducting Risk Assessment for new Vendors & Suppliers, Managing Vendor Lifecycle for Suppliers/IT Vendor/Business vendors.Periodic Review & Risk Assessment of GO Systems & QA Process.Conducting Gap assessment on process level.Organizing quality awareness programs and imparting training within the organization as per GxPguidelines.Implementation of IMS Standards (ISO 9001, 27001 & 14001)at organization level.Exposurein implementing quality planswith focus on optimum utilization ofresources with minimum cost.
Experience
Sr Executive
May 2023 — Present · Hyderabad, IN
Education
Riper
Bachelor of Pharmacy - BPharm
2011 — 2015
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