Validation Analyst / Tester

Minneapolis, MN

PHONE: (401) 206-0763

• Extensive 6 years of experience as a Validation Engineer/Technical Writer in the Pharmaceutical / Medical Device Industry with comprehensive understanding of Systems testing and technical documentation.
• Competent in Quality Systems and Standards (cGLPs, cGCPs, and cGMPs) and Regulation of Drugs and Medical Devices.
• Good knowledge related to 21 CFR part 11: Electronic records, Electronic signatures and Audit trials in validation, LIMS, Gap Analysis and Remediation Plans.
• Strong background in writing, reviewing and modifying Validation Master Plan (VMP), IQs, OQs, PQs, Validation Summary Reports (VSR) and Standard Operating Procedures (SOPs).
• Well acquainted with every phase of Software Development Life Cycle (SDLC) and Validation Life Cycle (VLC).
• Extensive experience with Laboratory Information Management Systems (LIMS) and integration with equipments (HPLC, Spectrophotometer).
• Working knowledge in validating Adverse Event Reporting Systems (AERS) and Scientific Data Management Systems (SDMS).
• Experience in working with various biomedical instruments and performing maintenance and safety measures.
• Highly motivated, organized and target oriented team player with effective communication and coordinated skill set.
• Leveraged on various opportunities to develop strong leadership skills.

Master of Science, Biotechnology, Texas Tech University.
Bachelor of Technology, Biotechnology, India.


Zimmer Holdings, Minneapolis, MN
Validation Analyst / Tester
Aug 2014 – Till Date

• Participated in drafting a UAT script for an upgrade of Lab ware LIMS and reviewed the executed test scripts for approval
• Collected requirements and coordinated meetings with LIMS team, project team and the vendors
• Developed test plans and test scripts based on user requirements using HP Quality center, executed them and generated reports
• Maintained the workflow and kept track of deviations ensuring full traceability
• Developed and reviewed the Requirement Traceability Matrix (RTM) to track test cases against the requirements
• Created cleaning cycle development strategies for the equipment used in the facility including parts washers, process vessels, chromatography columns, CIP, centrifuge
• Worked on interpreting the results, investigations and report writing
• Created, reviewed and updated the documents using Documentum
• Participated in the review of system administration SOP
• Involved in keeping track of changes or progress of QA processes and maintaining the existing processes
• Conducted gap analysis to identify possible gaps in the processes
• Participated in QA reviews to evaluate compliance with requirements
• Performed and implemented quality reviews of product documentation.

Gemini Pharmaceuticals, Commack, NY
QA Engineer
Jan 2014 – July 2014

• Involved in the calibration of HPLC and GC, and checked its accuracy, detection limits, noise level, precision, reproducibility, repeatability and robustness.
• Developed and executed IQ, OQ and PQ protocols, prepared the VSR to summarize all the documentation and instrument validation activities.
• Created templates for method validation protocol, method validation report, standard test method.
• Gathered URS and FRS for the Chemstation Software and its integration with LabWare LIMS.
• Prepared documents for Test cases for Integration, Functional Testing and User Acceptance Testing using Quality Center tool.
• Reviewed and drafted Standard Operating Procedures (SOPs) and User Manuals for the equipment and associated software to ensure they meet FDA requirements.
• Maintained Requirement Traceability Matrix (RTM) to track requirements.
• Assisted in initiating and conducting Gap Analysis and Remediation Plan for lab equipment and software interfaced with LIMS for 21 CFR Part 11 compliance and prepared Deviation Reports.
• Reviewed and carried out UAT, Positive testing, Negative testing, Regression testing for the Chemstation software.
• Also performed non- functional testing like Performance Testing, Stress Testing, Documentation Testing for the software.
• Involved in the validation of equipment and software associated with the Process Validation for manufacture of small volume Parenterals and automated filling.
• Prepared specification documents for Labstation module of LIMS and created test scripts for positive, negative, regression and the validation of Labstation module for interfacing lab instruments with LIMS Lab Ware.
• Monitored the dry runs for the labstation module and changed test scripts accordingly for the events generated.

Biota Pharmaceuticals , Alpharetta, GA
Validation Engineer
Aug 2012 – Dec 2013

• Involved in preparation of Validation Deliverables (Validation Plan to Validation Summary Report) of involved systems software and TrackWise.
• Interacted with the users, TrackWise developer team to qualify configured modules in TrackWise web team access and TrackWise administrator.
• Created and maintained validation documentation for assigned products/projects.
• Design validation plans, oversee execution of the plans and report validation activities on validation summary reports.
• Responsible for managing the discrepancies and maintaining the Discrepancy Logfile.
• Used ComplianceWire to issue the training to the end user and local Administrator.
• Involved in revising the SOPs for different sites.
• Was involved in resolving issues with Sparta System faced during the upgrade.
• Involved in project scheduling and deciding Timelines for activities related to validation.
• Prepared Requirement Traceability Matrix (RTM) to track requirements and to co-relate with the conducted test cases using QC Responsible to define test Requirements, run manual and automated tests, add and track defects using Mercury Quality Center.
• Responsible for creating and executing Test Scripts in accordance with Good Testing Practices and Good Documentation Practices.
• Designed Validation of Instrument Systems and ensured compliance with quality system requirements. Prepared protocols for following cGLP and cGMP procedures.

QuaDPharma, Clarence, NY
Validation Analyst
Jan 2011 – July 2012

• Validated the Adverse Event Reporting System (ARISg and Argus Safety), EDMS, GxP Assessment database, Change Management System, Clinical data management System (CDMS)
• Built the test cases, test procedures and test reports for verification.
• Reviewed the User Requirement Specification (URS) and the Functional Requirement Specification (FRS) document and analyzed the causes leading to discrepancies and failure of the pre-executed test scripts.
• Conducted various types of testing: User Acceptance Testing, Smoke Testing, Black Box Testing, Load and Stress testing using manual and automated testing tool
• Tracked, Investigated and resolved Bugs and defects using HP Quality center, win runner.
• Prepared Deviation Reports when the test criteria did not meet the acceptance criteria.
• Developed Requirements Traceability Matrix (RTM) to map the user requirements to the functional requirements, design specification and the IQ/OQ/PQ test script references.
• Developed, Modified and reviews SOPs, Operating Manuals, SWPs, and User guides
• Developed Change Control forms by determining the Technical Impact, Business Impact using TrackWise and developed the Change Plan to be executed for the Change Controls.
• Instructed the guidelines for quality issues during regulatory agency inspections, quality events investigations, and CAPA discussions.
• Provided reports to management related to timely CAPA implementation or other issues
• Developed the Validation Summary Report to provide a summary of the validation activities and executed deliverables.
• Archived all the validation packages using unique code identification in a centralized repository.
• Developed and conducted the Data Migration between obsolete and new systems.
• Prepared System Problem Report (SPR) Forms that proves a high degree of assurance regarding the root causes of the failures in the pre-executed copy and the resolutions taken to resolve the issues.

Cordis Corporation, Warren NJ
Validation Analyst
Mar 2009 – Dec 2010

• Designed and developed validation documents for research laboratory including hardware and software Installation Qualifications (IQ), Operational Qualifications (OQ), work instructions, best practice guidelines, and other methodology documents.
• Coordinated with System Analyst, Project Manager, and Business Analyst to setup the pre-validation and Validation environment to execute the scripts.
• Developed Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase. Documented Test Plans, Test Scripts and Test Cases for the User Acceptance testing.
• Analysed Test Scripts to be complaint with 21 CFR Part 11 which included Audit Trail Functionality, Data integrity, Data Security and Electronic Signature Functionality.
• Executed test script to test for functionality and regression testing using Win Runner 7.0 I automated load tests using Load Runner 7.5 for testing response time across network application server and database server and tracked and reported bugs using Test Director 7.0
• Worked particularly on LIMS, handling data for lab and also processing, tracking, storing and reporting various analytical data and records. I worked both on static data and dynamic data.
• Prepared specification documents for Labstation module of LIMS and created test scripts for positive, negative, regression and the validation of Labstation module for interfacing lab instruments with LIMS Lab Ware.
• Performed Computer System Validation Risk Assessment to meet the required regulatory specifications. I was responsible for development of Remediation Plans for components that were not full and mostly compliant.

  • Updated 7 years ago

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