Over 5+ years experience as a QA/Validation Analyst in Computer System Validation, Validation Engineer, Validation of Equipments, Testing and Technical Documentation for Pharmaceutical and Biomedical Industries.
*Significant experience in working with 21 CFR Part 11, 50, 56, 58, 210, 211, 820, 314 and components of GDP,GLP, GCP,ICH and cGMP Quality systems and standards
*Expertise in documentation for all aspects of computer system validation(CSV), technical writing and reviewing of Validation Protocols (IQ, OQ, PQ)
*Skilled in validation of pharmaceutical equipment like HPLC, autoclaves, incubators, spectrophotometers, and gas chromatography
*Experienced in using automated testing tools like Quick Test Professional and HP Quality Center
*Experience in validation of Laboratory Information Management System (LIMS),
*Performed risk assessment using the FMEA methodologies and Gap Analysis
*Developed Remediation Plans, and designed Requirement Traceability Matrix (RTM)
*Conducted Statistical Process Control (SPC) to reduce process variability and for process improvement
*Experience in validating Adverse Event Reporting systems (AERS), used Documentum for managing documents
*Developed and analyzed Test Plans, Test Scripts and Test Summary Reports (TSR)
*Involved in conducting Manual Testing and Automated Testing of the Software Application like Quick Test Professional
*Comfortable in writing complex SQL and PL/SQL Queries
*Excellent knowledge in Software Development Life Cycle (SDLC) using Water Fall Model and Validation Life Cycle (VLC)
*Exceptional analytical and communication skills, with an ability to work independently as well as within a team environment
*Performed Gap Analysis and developed remediation plans.
*Experience with Commissioning, URS, FAT, SAT, VAT and RTM documents.
*Develop (Clean in place), COP and SIP parameters for the manufacturing Equipment.
*Authored and approved Cleaning validation protocols.
QA/ Validation Analyst, 10/2015 to 07/2017 Genzyme – Framingham, MA
The project involved, validation of Adverse Event Reporting System (AERS) that helped in tracking products post market release and maintaining records for the company in compliance with the 21 CFR part 11 requirements using GxP / GLP / QSR standards.
Analyze and tested the 21 CFR Part 11 Compliance Tracking Applications that was designed to track down the applications currently being used to comply with FDA regulations and GAMP.
The Computer systems were also validated for compliance with 21 CFR Part 11.
Analyzing specifications, functional requirements, developing and modifying Test Plans and Test Cases.
Validation of Adverse Event Reporting Systems (AERS) and used Documentum for managing documents.
Administrating HP Test Director for Quality Center and automation of manual processes using Quick Test Professional.
Involved in Execution of the Test Scripts and writing Test Summary reports.
Performed both Manual and Automated testing of the applications.
Perform Load, Stress and Performance testing using controlled features to enhance testing process.
Involving in planning, scheduling, and running tests, Bug reporting & tracking and manage the bug status and executing the test cases.
Helped in performing risk assessment using the FMEA methodologies.
Participated in designing risk analysis of the finished product and processed risk analysis of various manufacturing processes.
Conducted Statistical Process Control (SPC) to reduce process variability and for process improvement.
Used Mercury Interactive Test Director for Test Planning, Test Designing, Test Analysis, Test Execution, Defect Tracking and Test Evaluation.
Troubleshoot & resolved many test scripts issues that required immediate attention.
QA/ Validation Tester, 05/2013 to 06/2015 Covidien – Norwalk, CT
Covidien brands are among the most well-known and respected in the healthcare field.
Quality and reliability are their hallmarks.
They have a history of developing and manufacturing high-quality products in a cost-effective manner.
As a system tester, I was involved in validation of LIMS that stored information of all the inventories involved in drug manufacturing.
The application also stored vendor-specific information.
Designed and Developed System Test Plan.
Assisted in the development team in documenting the User Requirements Systems.
Worked with the QA team to develop Business Requirement Documents (BRD).
Used automated testing tools like Quick Test Professional and HP Quality Center for testing systems.
Prepared IQ's, OQ's and PQ's.
Participated in compliance audits of systems, general assessments, risk assessments, 21 CFR Part 11 assessments.
Responsible for User Interface Testing and User Acceptance Testing.
Supervised, wrote and reviewed the Test Scripts during System Test according to FDA regulations and GAMP.
Analyzed Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21 CFR Part 11 rules set by FDA.
Worked on validating customized Electronic Study File (ESF) that is designed to store the clinical data trial information using Documentum.
Developed and maintaining Requirement Traceability Matrix (RTM).
Perform various types of testing like Unit testing, Negative testing, Sanity testing, System Testing, Integration Testing, Black Box testing, Front end testing, Positive testing, and Regression testing.
Attended bi-weekly meeting with the project Manager and the Management to brief them about the progress of the project.
Biogen Idec – Cambridge, MA
Develop, execute and report on cleaning protocols to support the manufacturing needs at a consumer healthcare facility producing OTC, and cosmetic products.
Investigation and documentation of the resolutions of deviations is required.
The position will report to the head of cleaning validation for the site in addition to the validation department manager.
Perform swab sampling and visual sampling.
Support non-cleaning validation projects as departmental needs dictate.
Work with cross functional teams to determine project requirements and align schedules.
Maintain training and knowledge of industry standards and practices.
Drafted equipment cleaning SOPs for use by manufacturing personnel in daily operations.
Serve as project team member to provide coordination between the operations, quality, laboratory, and validation departments.
Execute projects designed to remediate audit observations.
Train others in cleaning SOP practice on an as-needed basis.
Bachelor of Science: Chemical Engineering, 2008 BAPATLA ENGINEERING COLLEGE - BAPATLA Chemical Engineering