Naveen Kancharla                                                                                                                 

Quality Engineer

Naveen is a quality engineer with over 6 years experience working in the FDA regulated industries.   He has extensive hands on software experience developing and executing validation strategies, master plans, protocols and final reports. Naveen is dedicated, motivated and hardworking professional who possesses excellent communication and interpersonal skills.

EXPERIENCE…

• Implemented and validated Oracle AERS v4.5, Documentum v5.0, Wonderware Lot Tracking System, Waters Empower Build 1154, Maximo v5.2, PRISM 7.1, PerkinElmer AssureID software, ARCserve v9.0, NuGenesis v5.2, Calibration Manager v4.0.
• Documented, debugged  and upgraded an existing production line with  diagnostic capabilities. Control system consisted of an Allen-Bradley  Control-Logix 5000  control system with multi-Axis Servo pick and place units .
• Performed inventory analysis, based on the verified inventory, implemented the Risk Analysis to determine the extent of validation, qualification and/or verification.
• Generated SOPs, planned and facilitated implementation of 21 CFR Part 11 - Electronic Records, Audits, inspections, and facilitated the implementation of Quality Systems in line with SDLC requirements.
• Generated user/functional requirements (URS/FRS) for computer-related systems in accordance with predicate rules and 21 CFR Part 11
• Reviewed all aspects of the Computer Systems Validation Lifecycle in accordance with FDA regulations, 21 CFR Part 11.
• Responsible for validating various software features such as Auditing/Versioning, Client Timeouts, User Stamp/Timestamp, Sample Logging etc.
• Developed and maintained guidelines and SOPs for the Validation of Computer Systems
• Responsible for development of Validation Master Plans, System Requirement Documents, Installation and Operation Qualification documentation
• Developed Traceability Matrix (TM) to track requirements for the Software Application Module
• Experience with programming PLCs including Allen Bradley SLC 500, MicroLogix 1000, RS Logix5, RS Logix500, Mitsubishi, and Modicon.
• Hands on experience with HMI (Human Machine Interface) including Wonderware and SCADA.  
• Proficient with electrical blueprints, electronic schematics, loop diagrams, control ladder diagrams
• Experience in development and execution of FTA/FMEA, Six Sigma Methodologies.
• Hands on experience in developing Test Plans, Test Cases and Procedures as well as execution of Manual and Automated Test Cases.
• Investigated software bugs and interfaced with developers to resolve technical issues.
• Reviewed and maintained Change Control, Version Control, Configuration Management SOPs.
• Implementation of SCADA (Supervisory Control and Data Acquisition) in a RTU (Remote Terminal Unit).

POSITIONS HELD…

• Quality Engineer                                       BioTeknica
• Quality Engineer                                        Bausch and Laumb
• Controls Engineer                                     Rocha Controls
• Quality Assurance Engineer                     Ranbaxy.
• Teaching Assistant                                   Osmania University

EDUCATION…

• B.S in Electrical Engineering                     Osmania University