Vijay Kumar

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Around 9 Years of professional experience as a Validation/Quality Analyst/Engineer in pharmaceutical/Healthcare environment with expertise in Computer system validation, Equipment validation, technical writing and QA testing in Food and Drug Administration (FDA) regulated environment.

Proven knowledge and experience to work in manufacturing, laboratory environment and quality systems regulated under USFDA, Good Automated Manufacturing Practices (GAMP5), ALCOA++ Drug Enforcement Administration (DEA) and Occupational Safety and Health Administration (OSHA) regulations and ICH guidelines.

Expertise in preparing technical documents for validation protocols including Validation Master Plan (VMP), User Requirements Specifications (URS), Functional Requirements Specifications (FRS), Design Specification (DS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Requirements Traceability Matrix (RTM), Validation Summary Reports (VSR), Test summary report (TSR), Standard Operating Procedures (SOPs), Gap Analysis, and Remediation plans.

Development and execution of Computer System Validation processes in the life science and healthcare industry, including validation of SaaS (Software as a Service), IaaS (Infrastructure as a Service), PaaS (Platform as a Service).

Create and maintain the Validation and QC project tracker for new and existing clinical studies. Update internal QC checklist for multiple clinical studies (Phase 1, 2) and retention of approved deliverables for QC archival.

Communicate any critical compliance risks noted from these activities to senior management by performing risk assessments via Risk Management tools like Failure Mode Effects Analysis FMEA.

Analyze test scripts to be compliant with 21 CFR Part 11 to test the Audit Trial and Data Security of the application.

Review and approve Programming Request forms related to SAS (SDTM update, Patient Profile, Ad hoc listings, External Data Conversion, JReview, Database Lock, Datacut, Tumor listing, SAE Reconciliation, Milestone and Hardlock updates as a QAV.

Review, pre and post approve Programming Request forms (PRF) and Post-Production change (PPC) forms for clinical studies along with QC script by verifying Objective evidence.

Experience in migrating the data/clinical study artifacts from PhexEview (Trail Master File/TMF) to Veeva Vault system for document repository and inspection/audit purposes. Performing Pre-post migration checks.

Working knowledge of ERP, EDMS (Enterprise Document Management System), Trackwise LIMS (Laboratory Information Management System), AERS (Adverse Event Reporting System), and CCMS (Change Control Management System).

Expertise with excellent knowledge in validating manufacturing equipment like Autoclaves and Flow Cytometer and clean steam, formulation tanks, analytical lab instrumentation such as balances, pH meters, TOC Analyzer, Densitometer, Wave system, ABL, Vi-Cell and SoloVPE systems.

Overall 2+ years of experience in healthcare and IT industry as Pharmacy Benefit/Quality Auditor.

Technical Skills

Validation

21 CFR Part (11, 210, 211, 820) URS, FRS, FRA

Validation Protocols (IQs, OQs, PQs), VSR, cGxP (GCP, GMP, GLP), ISO13485, SOPs, Audit Trails, RTM, Gap Analysis, Quality Assurance.

Testing Tools& Testing Skills

Load Runner, Quality Center, Regression Testing, Integration Testing,

Functional Testing, User Acceptance Testing (UAT), HP ALM

Equipment Handled

TOC Analyzer, Autoclave, Buffer hold tank, Wave, Vi-Cell, ABL, Wave, SoloVPE System etc.

Software/Enterprise Systems

MS office, LIMS(Labware LIMS), Jira, SharePoint, Oracle InForm, Trackwise, DataPro, Unicorn, ImageLab, Secure VPE, PhexEview VeevaVault (eTMF), and Valgenesis(QMS)

Project Methodology

Waterfall, Agile, V Model

Platforms

Windows OS, Mac OSX, ServiceNow

Professional Experience

Eisai Inc, Nutley, NJ

Sr. IT Quality Validation Consultant April 2020 to Oct 2023

Development of validation documents for all aspects per System Development Life Cycle (SDLC) methodologies, company guidelines, in accordance with Food and Drug Administration (USFDA) regulations, particularly 21 CFR Part 11.

Provided Validation/QC guidance regarding clinical data programming tasks for multiple clinical studies.

Reviewed, pre and post approve Programming Request forms (PRF) and Post-Production change (PPC) forms for clinical studies.

Supported IT team to validate ValGensis system by reviewing validation deliverables and conducted meetings with system and technical teams.

Reviewed/generated/validated electronic submission deliverables such as SDTM datasets and clinical study migration from GAE environment to ECCE (Eisai Clinical Computing Environment).

Performed Quality Testing/UAT of EDC system and test Management Tool like HP ALM.

Involved in development and execution of IRITS project for Request and Incident tracking system.

Reviewed and uploaded submission CRFs to EDGE system into specific clinical study and site location/folder for audit/tracking purposes.

Preparation of test plan and test strategy based on business requirements, technical/design specifications, and product knowledge.

Dry running the test scripts and supporting test execution and User Acceptance Testing (UAT) to make sure that all the user requirements are tested by the application.

Executed qualifications, commissioning, and decommissioning activities.

Performed validation & quality control to ensure all program development activities within the Oncology Business Group IODS follow established processes and ensure proper documentation and timely posting into the TMF as required.

Validation and QC support of clinical database design, reports & listings programs, SDTM conversion and related programming, postproduction changes, and implementation of programming tools within the IODS group.

Takeda pharmaceuticals, Brooklyn Park, MN

Validation and Quality Specialist Jan 2019 to March 2020

Responsible for Qualification/Validation of Quality control Laboratory and Manufacturing equipment/instrument hardware and software packages.

Worked with various software packages like DataPro, Labware LIMS Empower, Unicorn, SecureVPE, Vi-Cell XR, etc.

Perform calibrations in the following disciplines: Balances/scales, flow, temperature, conductivity, pressure, and UV among others in a GMP/GXP environment.

Responsible for developing and executing protocols related with installation, operation, and performance qualification, authorizing test scripts for TOC analyzer, Weighing Balances, Densitometer, particle size used in QC laboratory. Instruments like ABL analyzer, Vi-Cell, SoloVPE and Wave systems utilized in manufacturing units for various stages of Cell culture and Purification.

Responsible for developing Installation, Operational and Performance Qualification protocols by meeting all the system requirements (Operational, Functionality and Calibration), Design configurations (Software, Hardware), verifying the methods, SOPs and training documents related to equipment and computerized systems.

Familiarity with calibration of systems/equipment such as Chromatography Columns and skids, mixers, vessels, Controlled Temperature Units, and various benchtop support equipment.

Responsible for developing Installation, Operational and Performance Qualification protocols by meeting all the system requirements (Operational, Functionality and Calibration), Design configurations (Software, Hardware), verifying the methods, SOPs and training documents related to equipment and computerized systems.

Created and completed workflows for new and existing documents in LEADs (Document Management System).

RB Pharmaceuticals, Salt Lake City, UT

Validation Engineer/ CQV Sept 2018 to Dec 2018

Supported Commissioning and Qualification (CQV) of utilities like Reverse Osmosis (RO) purified water systems (WFI), Siemens Building Management System (BMS) Clean room HVAC includes N2 and Air Lines.

Authorized Installation Qualification (IQ) and Operation Qualification (OQ) Protocols for HVAC, IBC lift, and Floor Scale.

Involved in Installation Qualification (IQ) and Operation Qualification (OQ) of Floor scale weighing terminal, HVAC air handling units with dehumidifier.

Supported qualification of autoclaves, verification of protocols entries & test results analysis.

Performed Temperature mapping for Buffer Hold tanks, Bioreactors SIP by using KAYE Validator 2000 and AVS.

Validation of Autoclaves used in microbiology laboratory and manufacturing areas for various load patterns (Equipment load and Liquid load) and Temperature mapping.

Performed end to end Performance Qualification of Autoclaves used in Cell Culture and Purification Laboratories.

Merck Pharmaceuticals, West Point, PA

Validation Analyst June 2018 to Aug 2018

Authored and Edited the Design Specification plan for new data center qualification.

Reviewed, Edited the Validation Plan for Data centers for application of GPO throughout Merck site.

Worked with IT functional, technical team for qualification to Complete qualification of data center.

Created training documents and manuals for trainees on new data center setup and moves.

Drafted documentation for difference between Infrastructure Management Lifecycle (IML) and System Development Life Cycle (SDLC).

Drafted and involved in the execution of Performance Qualification of modified sample valves of Buffer hold tanks.

Drafting and Protocol Qualification (PQ) of Revalidation for Autoclaves.

Drawing steaming circuits in the P&ID and sample valve modifications using MS Visio.

Eli Lilly Pharmaceuticals, Branchburg, NJ

Validation/Quality Analyst Aug 2017 to June 2018

Verify steaming circuits in the P&IDs and Identifying low points and determining locations for placements of biological indicators for sterilization cycle qualification.

Involved in drafting commissioning and qualification documents for Autoclave and buffer hold tanks for various load patterns.

Performed cycle development studies for autoclaves, qualified bovie dicks testing procedure, empty chamber temperature mapping, loaded chamber temperature mapping for liquids & parts.

Maintained inventory of steaming and cleaning validation supplies and calibration due dates and re-calibration of Kaye, IRTDs, flow meters, pipettes etc.,

Installing calibrated Kaye validators for thermocouples and troubleshooting minor issues related to damaged thermocouples, cables, temperature baths etc.,

Performing pre and post calibration of Kaye validator before and after the qualification studies.

Working with EQV team to help in qualification of refrigerators, Autoclaves and Bioreactors using Kaye Validator for temperature mapping (acquiring extensive working knowledge on Data probes, Kaye Validator 2000 and AVS systems).

Maintain quality objectives and conduct accurate verifications, including, identifying batch record gaps, reporting, and escalating issues.

Reviewed cleaning validation protocols in accordance with FDA regulations and compiled Validation/ Summary report, conclusions, and recommendations for Revalidation policy.

Mylan Pharmaceuticals, Canonsburg, PA

Validation Analyst Feb 2017 to Aug 2017

Developed and executed OQ and PQ test scripts of various LIMS modules and generated Test Summary Reports. Interacted with the Lead user and wrote PQ scripts and was responsible for User Acceptance Testing (UAT).

Organized schedules, determined priority status, identified responsible individual(s) and project descriptions according to company standards.

Authored and Reviewed Rollout Strategy for Standalone remediation Project.

Authored Validation plan, URS, IQ, OQ and Traceability Matrix for Recycle Bin Restrictions for standalone remediation and General Use PC’s for the application of GPO throughout Mylan sites.

Worked with IT Team, functional and technical team for Infrastructure qualification projects.

United Health Groups, Hyderabad, India

Pharmacy Benefits Analyst/ Quality Auditor Dec 2012 to April 2015

Analyzed benefit requests and secure all necessary data to ensure appropriate implementation based on applied logic of RxCLAIM pharmacy claim adjudication system.

Worked with other cross-functional departments to implement new and maintain existing benefit plans and client pricing in the pharmacy claim adjudication system.

Research and respond to all claims processing inquiries from Client Management, Clinical, and other internal departments.

Update back-end database system by implementing logistics in AS-400 application, with latest inclusions and exclusions of dosage forms of United States Pharma Market.

Ran queries out of the RxCLAIM adjudication system to secure all necessary information to implement plan requests in PEGA and AS400 Applications.

Education

Masters in computer sciences and information Assurance; Wilmington University, DE, USA 2016

Bachelors in pharmacy; Jawaharlal Nehru Technical University, Hyderabad, India. 2012

Diploma in Pharmaceutical Sciences; State Board of Technical Education, Hyderabad, India 2009

Certification

Certificate Of Completion Six Sigma Green Belt from IIBA

Certificate Of Completion Quality Management for Operational Excellence Project Management Institute

Published Journal- Formulation and Evaluation of floating tablets containing Theophylline.

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