Akula Tejaswini

About Akula Tejaswini

Over 6+years of experience in Computer System Validation, Excel Sheet Validation and Corporate Quality Assurance in FDA regulated Pharmaceutical industries.Expertise in planning and executing validation activities - developing and maintaining validation documentation. Conducting Risk Assessments collaborating with cross functional teams. Proficient in SDLC, CSV Methologies and concepts of qualification protocols (IQ/OQ/PQ) to complaince with FDA 21 CFR Part 11, GxP (GMP, GLP, GDP) and GAMP 5 Standards. Performed Change Request, Initial Risks Assessments (IRA), GxP Assessments, ERES assessment, Audit trails and Change Impact Assessment. Author, Review and Approval of Validation Execution of Initial Risk Assessment (IRA),Failure Mode Effective and Critical analysis (FMECA), Validation Plan, IQ/OQ/PQ scripts, Traceability Matrix, Validation Summary Report, System Release. Pre-Post review, approvals of IQ/OQ/PQ to complaint as per Good Documentation Practices. Analyze, Review and approval of User Requirements Specifications (URS), Functional Requirements (FS), Configuration Specifications (CS) and Design Specifications (DS). Proficient in SDLC Methodologies- Waterfall, V model and Agile (Sprint planning and Scrum sessions). Proficient in Test management: HP ALM and JIRA. Developed Deviation/ Defects reports on root cause and resolution to close the defects. Author, Review and Approval of Test plans, Test scripts, Test Overview List and Test Summary Report. Involved in the regulatory, customer and Quality system related inspections for all computerized systems. Author, Review of System Retirement, Periodic Reviews, Periodic Review Schedule and Post Implementation Review activities of the applications.Handling of multiple validation projects and validation support in a timely manner.

Experience

1. Computer System Validation Engineer

   Tata Consultancy Services

   Apr 2022 — Present · Hyderabad, IN