Abheesh Reddy Bommareddy

Abheesh Reddy BommaReddy Email: [email protected] Phone: (732) 334-8757 Summary  Eight Years of experience in Lab Equipment Validation, Method Validation, Computer System Validation (CSV) Methodologies, Technical Writing and Quality Assurance in Pharmaceutical/Medical Device Industry with a strong background in performing Computer System Validation and Software Development.  In depth knowledge of FDA regulations 21 CFR Part 11 (Electronic Records and Electronic Signatures, Audit Trails and Security events).  Experienced in Data Migration of various Systems  Experience with entire life cycle of Computer Systems Validation including User Requirements Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment (VA) and System Design Specifications (SDS).  Experience in developing protocols, Executing tests and Constructing Summary Reports for IQ, OQ and PQ for validations in various pharmaceutical companies  Good experience in performing manual testing methods like Integration Testing, Black box Testing, Functional Testing, Regression Testing, Front end Testing and also automated testing tools like HP Quality Center, HP ALM.  In-depth knowledge in SDLC process  Experienced in Quality roles with a focus on document review, computer systems application management and validation, training, laboratory testing, and providing regulatory submission and audit/inspection support.  Followed agile and waterfall models in Software development Process.(SDLP)  Experience working with GxP’s like Good Laboratory Practices(GLP), Good Manufacturing Practices (GMP), Good Documentation Practice (GDP) andGood Clinical Practices (GCP) suites.  Experience in Preparation and maintenance of Test strategies, Test plan, Test Scripts and Test reports. As well as, preparation of Validation Summary Reports and Test Summary Reports.  Performed Regression, Integration, and User Acceptance (UAT) Testing.  Experience in automated testing tools such as Mercury Quality Centre (MQC) and Quick Test Professional (QTP).  Tracked and documented Change Requests using Mercury Quality Center. Technical skills: Tools: SOAP UI, Quality Center, QTP, WINSCP Operating Systems: Windows 95/98/2000/NT/XP/Win 7, Unix Web Technologies: XML, HTML Office Automation: MS Word, MS Excel, MS Visio, MS Project, MS Access Languages; SQL, PLSQL EDUCATION: Bachelors of Engineering in 2007

Work Experience Novartis, NY Sr. Validation Analyst Dec 2013 – Jun 2016  Systems and Equipments:  Electronic Document Management System (EDMS),  Maximo Implementation,  Olympus,Clinitek Atlas and Clinitek Status, Advia,  Lab Ware LIMSData Migration  ELN (Electronic Laboratory Note Book)  Stago, Waters Empower v3 Implementation Project Lab Ware LIMS, ELN and Waters Empower 3, Olympus:  Validated Lab Equipment’s Sysmex XE500, Olympus AU680, Stago Compact, Advia and Clinitek Status  Validated the functionality of hematology tests and chemistry tests including electrolytes, proteins and enzymes; coagulation tests; urinalysis; and blood gas analysis.  Performed all end to end validation activities for Lab Ware LIMS, and Empower3 and other laboratory equipmentsimplementation  Leaded a team of 3 members for validating the Systems and equipments within the allotted budget  Validated the Empower’s functionalities not limited to “Acquiring”, “Processing” the data from Olympus, HPLC and Gas Chromatography, FTIR, UV - VIS instruments (Instruments in LS manufacturing Space)  Implemented Waters Empower Chromatography Data system v3.  Authored User Requirements for Empower that include Search, Report requirements and Processing Data requirements  Authored Functional Requirements Specification for Olympus that covers functionalities like Acquiring, Analyzing and maintaining the report laboratory information  Developed Validation Plan for Empower with the integration to different client sites  Developed configuration specifications for the proposed system.  Olympus, Clinitek support - Provided SME input on deviations, investigations LIMSData Migration:  As part of Data migration validated the LIMS Data Migration Java Program  Assisted in drafting Data Migration Plan and Data Migration Specification  Authored Data migration requirements  Authored FBD and Test Plan for LIMS  Experienced with Migrator tools like LD (LIMS Data Migrator) and comparison tool and tested the transferred Data (ETL)  Authored, executed, reviewed Data Load verification protocol (PQ)  Authored, executed, reviewed test protocol to validate the end to end migrating program  Performed the Sampling techniques for verifying the Data load in LIMS Responsibilities:  Used TrackWise to create new Parent Record (PR’s), Child Records for IT Infrastructure that contain Description, Implementation Plan of change request, Investigation Tasks, Corrective Actions, etc.  Used TrackWise for Application Infrastructure Maintenance by authoring Infrastructure Qualification protocols (Infrastructure Configuration Specification, Infrastructure IQ etc.)

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Used TrackWise to provide secure access to authorized users to initiate new problems and incidents of any type into the system- restrict users to be able to create new records only for their relevant areas and responsibilities. Authored System Workflows for CAPA, Change Management Modules of Track Wise Authored BRD Documents to list all modules Requirements for LIMS Related electronic files were attached as reference documents using TrackWise so that they can be reviewed along with the overall request Performed Data Migration for LIMS system Involved in detail workflow of Empower Data Acquiring functionalities Worked on Maximo version 7.6 core modules (Corrective Maintenance, Preventive And Emergency Maintenance, Asset, Work order tracking, General ledger module, Job plan, Data Sheets) Validated the Java migration Program and implemented in Qualified environments Responsible for Validating the control of report laboratory information Involvedin authoring the migration paths. Authored migration snapshots for database backup and restoration and also performed configuration changes with snapshots in place. Worked closely with vendor team to fix the bugs found during the dry runs. Prepared and Documented Incident Reports (IR) for Olympus, Clinitek, Advia, Stago Routed documents for approvals in Documentum. Developed and maintained the Requirement Traceability Matrix (RTM) for the application. Authored for storing and maintaining the documents to comply with 21 CFR Part 11 requirements. Used HP ALM for defect tracking Performed front end testing, positive and negative testing, GUI testing, and regression testing Performed GAP Analysis and prepared Remediation Plans for equipment’s such as Olympus Conducted reporting and tracking of defects using Quality Center.

Valeant, NJ Sr. QA/Validation Analyst Aug2012-Oct 2013  Systems: Electronic Laboratory Notebook (ELN),Advia, Clinitek Status, Stago, Olympus,Track and Trace, LIMS Implementation, Empower V3  Implementation activities of Olympus, Advia, Stago, Clinitek, Lab Ware LIMS, ELN and EMPOWER V3:  Authored user requirements for Olympus, Advia, Stago and Clinitek  Authored functional Requirements based on the User needs of Olympus, Clinitek, Stago  Validated the use of Equipment’s for Laboratory Diagnostics activities such as hematology tests and Urinalysis  Performed all end to end validation activities for implementation of LIMS and EMPOWER  Authored LIMS and EMPOWER Validation Plan covering all impacted sites  Validated LIMS Storage of Materials in the Sample Room, Assignment and Data Entry, Review and Approval of Test Results functionalities  Validated Stability Study requirements of LIMS and Olympus, Clintek Equipment  Validated Empower functionalities such as Processing Data, Reporting and Search requirements  Validated the Crystal report specifications by authoring report protocols  Validated Acquiring, Analyzing, Sample set capabilities of EMPOWER

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Worked on interface testing between HPLC, GC (Instruments in LS manufacturing Space) Authored User Requirements, Functional Requirements, Design Specifications for LIMS and EMPOWER in compliance with 21 CFR Part 11 requirements  Worked on acquiring, sample set and other system workflows of LIMS and EMPOWER  Responsible for writing and executing Installation qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ) protocols to check installation and successful operation and performance of the applications.  Involved in developing Test Plans and Summary reports for the LIMS system implementation and other systems.  Created and maintained the Requirement Traceability Matrix (RTM) for LIMS LIMS Interface Validation:  Validated various Oracle SOA interfaces between LIMS and Asset Management system  Assisted in deployment of interfaces in validation and production environments  Validated end to end transformation rules and design specifications of LIMS Interfaces  Initiated change controls for various GXP and Non GXP systems  Coordinated with Change control core team board to perform GXP applicable assessment on the proposed change  Authored and closed various change controls for the Infrastructure changes  Performed all Infrastructure Qualification activities required for implementing a system at the client site  Expertized in authoring BRD’s and detail workflows of Systems  Responsible for authoring Infrastructure Qualification procedures  Authored System Specifications for Infrastructure Qualification  Routed documents for approvals in Documentum.  Initiated workflows in Share point for informal reviews.  Conducted Risk assessment meetings to determine the criticality of the system.  Responsibilities:  End to End testing of ELN modules such as Project Manager, Sample Manager, and Stability Manager.  Validated 5 Major reports of ELN, LIMS  Testing documentation development, review, pre-approval, execution, and post-approval of IQ, OQ, and PQ.  Involved as primary member with ELN Team representatives and Subject Matter Experts to develop system requirements  Coordinated with Infrastructure Team to develop HW/SW design for system implementation.  Assisted Business Analyst in the assessment and gathering of supporting documentation, such as Test Method SOPs, Material Specifications, Test Data Sheets and Reports, etc.  Provide guidance on best practices to follow guidelines set by the FDA for electronic systems as defined in 21CFR Part 11  Used HPQC for Defect Management  Review documents related to Quality Systems such as User Training Materials  Involved in preparing Remediation Plan for the IMS Legacy System  Assisted Development Team with configuration of the Formulator ELN product.  Facilitated Change Control processes related to application or system updates made to the production system.  Developed system-specific Standard Operating Procedures (SOPs) for the utilization of the ELN.

Boston Scientific, MA Validation AnalystJul 2009– Jun 2012  Systems: Maximo,  TVT (Text Verification Tool),  TrackWise Support, AERS, TruCompare, Platue  Lab Ware LIMS and Scientific Data Management System Responsibilities:  Analyzed User Requirements and authored user requirements document, Functional Requirement document for LIMS  Create change requests Parent Record (PR’s), Child Records for IT Infrastructure and IT Application teams  Performed Data migration that includes Data Verification and Tool validation of Maximo and SDMS systems  Authored Verification protocols for Data upload testing and Tool qualification  Tested various Maximo modules such as Asset, Work order tracking, General ledger module, Job plan, Data Sheets) after the Migration  Assisted in authoring System specification document.  Developed, implemented and executed test methodologies and plans to ensure product quality  Created test plan and detailed test cases using Quality center  Tracked changes made to the requirements, tests and defects using Quality center.  Created documents to comply with the appropriate FDA regulations including 21 CFR Part 11 requirements.  Responsible for reviewing and executing IQ/OQ/PQ test scripts.  Responsible for writing the Validation Report that also includes Traceability Matrix, Anomalies and Remediation Plan  Reviewed all the Validation Deliverables as per SOP Guidelines and in accordance with Good Documentation Practices (GDP)  Responsible for performing User Acceptance Testing (UAT) for the application.  Developed User manuals and Training manuals.  Performed configuration of workflows for a project by defining the activities and also tested the configured project  Reviewed the CAPA, QA Audit, Change Control workflows using TrackWise  Updated the Requirement Traceability Matrix (RTM) upon completion of Functional Verification and User Acceptance Test execution  Interacted with Subject Matter Experts (SME) to understand and document the workflow and functionalities on different modules. Reddy Laboratories, India– Validation Analyst Aug 2007– May 2009  Systems: Text verification Tool (TVT),  LIMS Upgrade,  HPLC, GC, Autoclaves, PH meter and FTIR Responsibilities:  Involved in gathering the User Requirements from the System Owners document for all the software components.  Worked on different modules of LIMS

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Developed FRS (Functional Requirements Specification) and DS (Design Specification) from the URS (User Requirement Specification) of LIMS and TVT applications Responsible for reviewing and documenting Validation Plan, OQ/PQ protocols and Validation Summary Report. Tracked changes made to the requirements, tests and defects using Quality center. Created documents to comply with the appropriate FDA regulations including 21 CFR Part 11 requirements. Automated Test scenarios for GUI, Functionality, Boundary, Security and Regression Testing Authored Data Migration Policy. Developed and updated Requirement Traceability Matrix (RTM). As well, Developed test plans and test scripts and involved in executing them for validation testing.