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    Software Validation (CSV) - Quality Engineer Resume - Hire IT People - We Get IT

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    Ashish Laller
    This document summarizes the experience and qualifications of a Software Validation and Quality Engineer. They have extensive experience validating software systems in regulated industries like pharmaceuticals and medical devices. They have expertise in writing documentation like validation protocols, test plans and procedures to ensure compliance with FDA and other industry regulations.

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    © All Rights Reserved
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    Software Validation (CSV) - Quality Engineer Resume - Hire IT People - We Get IT

    Uploaded by

    Ashish Laller
    72 views5 pages
    This document summarizes the experience and qualifications of a Software Validation and Quality Engineer. They have extensive experience validating software systems in regulated industries like pharmaceuticals and medical devices. They have expertise in writing documentation like validation protocols, test plans and procedures to ensure compliance with FDA and other industry regulations.

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    Software Validation (CSV)- Quality Engineer Resume - Hire IT People - We get IT

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    This document summarizes the experience and qualifications of a Software Validation and Quality Engineer. They have extensive experience validating software systems in regulated industries like pharmaceuticals and medical devices. They have expertise in writing documentation like validation protocols, test plans and procedures to ensure compliance with FDA and other industry regulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    72 views5 pages

    Software Validation (CSV) - Quality Engineer Resume - Hire IT People - We Get IT

    Uploaded by

    Ashish Laller
    This document summarizes the experience and qualifications of a Software Validation and Quality Engineer. They have extensive experience validating software systems in regulated industries like pharmaceuticals and medical devices. They have expertise in writing documentation like validation protocols, test plans and procedures to ensure compliance with FDA and other industry regulations.

    Copyright:

    © All Rights Reserved
    Download as PDF, TXT or read online from Scribd
    Download as pdf or txt
    of 5

    hire IT people

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    Software Validation (csv)/ Quality Engineer


    Resume
         4.00 /5 (Submit Your Rating)

    SUMMARY:

    Professional experience with Validation of Software, Computer Systems/Testing used in


    Laboratories, Clinical, Pharmaceutical/ Medical Devices and Biochemical Industries. Excellent
    working experience in validating the computer systems in as per CAPA, FDA regulations and
    GLP, GMP, GCP guidelines. Contributed to the success of Inform, Clintrial, Confidential
    applications and managing the team members by motivating the team and by conducting
    meetings, periodic review.

     Excellent Experience in Validation of Computer applications such as Inform, Clintrial,


    Clintrace, Oracle Confidential, Routers, Switches, Remedy, Sample Manager,
    Documentum, LIMS, Data Integrity, Pharmaceuticals/Biologics
     Experience in Developing and enhancing the Standard Operating Procedures (SOPs) as a
    part of the SOP program.
     Expertise in conducting Risk Assessment, 21 CFR Part 11 Assessment, Security
    Assessment, and documenting as per GAMP 5 guidelines. Heavy emphasis on Computer
    Systems Validation, Instrument/Equipment Validation, Cleaning and Process Validation
    and Software Quality Assurance with profound knowledge of FDA regulations,
    documenting validation protocols, Documentum, LIMS, AERS
     Develop Software Test Plans (STP) and protocols (both manual and automated using
    scripts), Software Requirement Specifications (SRS), Software Development Plan (SDP),
    Software Design Specifications (SDS), Customer Requirement Specifications (CRS),
    Software Configuration Control (SCC), and software manuals.
     Hands - on Test Method Validation (TMV), and R&D experiences.
     Worked with many Automation and process systems like DCS, PLC, HMI, custom
    software systems etc. for unit operations like compounding, batching, cleaning, freeze

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    drying, SIP, filling, packaging.
     Develop test scripts and execute V/V software tests both automated (Rational Visual Test
    6.0) and manual.
     Expertise in using Documentum, Sharepoint, TrackWise, Laboratory Information
    Management System (LIMS), Windchill, HP Quality Center, Adverse Event Reporting
    System (AERS).
     Experience in documenting User Requirements Specifications (URS), Functional
    Specifications (FS) and Design Specifications (DS) documents.
     Expertise in documenting Design Review (DR) and Qualification Protocol (QP), Technical
    Writing. Excellent experience as Validation Specialist and in-depth involvement in writing
    test scripts for Installation Qualification (IQ), Operation Qualification (OQ) and
    Performance Qualification (PQ).
     Experienced in Laboratory Method Validations, Process Validations, Cleaning validations,
    Building Automations Systems, Microbiology Laboratory Validations, Facility
    Commissioning, Legacy Equipment Validations etc.
     Excellent understanding of Software Development Life Cycle (SDLC).
     Hands on experience in Manual Testing of various applications and developed Test
    Plans, deliverables, entry and exit criteria and documented the User Acceptance Testing
    based on the User Requirements and also assessed the risk and security aspects for the
    application.
     Well versed with MS O"ce. Excellent oral and written communication skills.

    TECHNICAL SKILLS:

    Methodologies: Agile, Waterfall, V-model, Spiral

    Regulations GMP: FDA 21CFR-Part 211, GLP (21CFR Part 58, QSR (21CFR Part 820), ERES
    (21CFR - Part 11, Gamp 4/5, SOX

    Software: MS O"ce, MS Project, MS Visio, Labware LIMS, Watson LIMS, Sharepoint, eRoom,
    Oracle Argus Safety AERS, Spectrophotometer, Astra Data Acquisition software, Agilent
    Chemstation, Empower, SQL, TrackWise, LIMS, Documentum (V 6), Windchill (V 9.1), MATLAB,
    JMP, SAS

    Testing Tools: Quality Center, Crystal Reports, Win Runner 6/7.6, Load Runner, Test Director

    Programming: C, C++, SQL, PL/SQL, Visual Basic, PL7 ladder logic

    O.S: Unix, Linux, Windows DOS

    Database: Oracle 8/9i, MS Access, SQL

    PROFESSIONAL EXPERIENCE:

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    Confidential, Mahwah, NJ

    Software Validation (CSV)/ Quality Engineer

    Responsibilities:

     Documented URS, IQ, OQ and PQ for Version Control and Data Solutions
    systems. Reviewed URS and FRS documents for Jira application. Documented Validation
    Plan, Test plan, Functional Specifications, Qualification Protocol and Test cases.
     Participated in meetings with IT Project Manager, Validation Analyst in order to track
    project status and to verify the project progress complies with the project schedule.
     Created templates, procedures, SOPs and manuals for validation including infrastructure
    qualification, analytical instruments, lab equipments, spreadsheet and SAP based
    applications.
     Created Data Migration scripts and monitored the extraction and transfer process.
     Gathered requirements, reviewed and approved Requirements Specification document
    as part of IT tools validation. Reviewed and approved related documents such as
    Validation Plan, Test plan, Requirements Specification, Functional Specifications,
    Qualification Protocol, Test cases.
     Used Quality Center for managing Requirements, Test Plan and Test Cases. Wrote Test
    plan, validation plan for the validation of IT tools.
     Reviewed the Functional Specifications document for DOORS. Reviewed the SOPs and
    policies and regulations.
     Involved in Validation of the labeling application and associated hardware in accordance
    with FDA's 'General Principles of Software Validation' and 21 CFR part 11 compliance
     Authored and reviewed Design Specifications and Functional Specifications as per the
    needs of the client sites.
     Developed Validation Protocols (IQ, OQ, PQ) as per the specifications and requirements.
     Responsible for handling the objective evidence, managing the associated deviations
    and escalating the system issues.
     Involved in analyzing possible Issues, Risk assessment and mitigation and maintaining
    Deviation Records.
     Initiating and updating Change Control tickets for CAB and CCB reviews as per Quality
    System Impact procedures.
     Authored, reviewed and maintained Traceability Matrix for various testing cycles
    planned for multiple global level site deployments.
     Developed Training Plans and SOPs as per FDA Quality System Regulations (QSR), ISO
    13485, ICH Q10.

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     Participated in the production support activities and Continual Service Improvements
    (CSIs) of the systems and processes.
     Trained Testers and Business Users on Test Script Execution and Evidence Handling as
    per FDA's Good Documentation Practices.
     Involved in management, maintenance, retrieval and archival of documents and records
    electronically using SharePoint.

    Confidential

    Validation Analyst
    Responsibilities:

     Reviewed Change Requests for di#erent bugs and fixes those arise during the Oracle
    Confidential Release Management Project.
     Reviewed, organized Change Requests and approved after verification of completeness
    of documentation.
     Assessed Quality, Compliance, and Application, Business and Infrastructure impact of
    the Change and also the impact if the fix is not moved to Production.
     Assessed Risk and prioritized Change Requests and ensured the Change Requests are
    moved accordingly.
     Drafted Test Plan, Implementation Plan and Recovery/Back out Plan for Oracle
    Confidential based application.
     Worked with Web sphere Customer Center for maintaining record of the customers
    across the enterprise. Conducted Load testing and monitored performance scenarios
    with HP LoadRunner.
     Worked with the Development team, Change Management team, Technology, Business
    and Compliance approval teams to move the Change Requests to di#erent
    environments.
     Worked with the developers in creating Setup Logs, Patch Logs for the fixes that involved
    Setups and Patches.
     Reviewed and enhanced Change Requests created by the Change Control team.

    Confidential

    Validation Specialist/Test Analyst


    Responsibilities:

     Monitored the testing conducted by QA dept. and documented the Validation Summary
    Reports.The project at Medimmune mainly involved working on Regulatory applications.
     Involved in coordinating the approval of IT for Insight Publisher Upgrade through

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    authorized Request for Change- RFC.
     Co-ordinated with Regulatory Operations to open a new Validated System Change
    Request in TrackWise to document the implementation of Insight Publisher Upgrade.
     Drafted the Installation Qualification Protocol (IQP) as per release notes provided by for
    implementation of insight Patch.
     Involved in review, update and pre-approval of IQP and OQP by uploading the
    documents in Aegis EDMS involving System Owner, Validation, Information Technology,
    and Quality Assurance
     Involved in the post execution documentation (as per GDP) of executed IQP, and OQP
    and coordinated with System Owner, Validation, Information Technology, and Quality
    Assurance for post approval.
     Assured that the VSCR (TrackWise) and RFC (SharePoint) are in appropriate status to
    ensure IT Compliance as per Medimmune standards to comply with FDA regulations.

     Report an issue

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