Name: KULVAS

Email: adiqxp@r.postjobfree.com

Phone: 609-***-****

PROFESSIONAL SUMMARY:

Over 8 years of experience as a Computer System Validation professional with a demonstrated record of achievement working on GxP (GCP, GLP, GMP) computer systems.

Implemented Computer System Validation in compliance with 21 CFR Part 11 and GxP FDA Regulations and QSR 820

Experience in Validating SAP ERP Application(PTP and OTC, PTP-OTC integration, PTP-MDM Integration, OTC-MDM Integration).

Experience in validation of various IT systems Oracle EBS (Advanced Supply Chain Planning, Quality, Accounts Receive bales, General Ledger, BOMS, Routings, WMS, Procure to Pay), LIMS (Laboratory Information Management System), Track Wise (CAPA, Complaints).

Experience in validating End to End TrackWise and Veeva Vault Application – EDMS, CTMS, QMS, CAPA, Complaints workflows.

Hands on experience on HP ALM (Requirements, Test Plan, Test Lab and Defects modules).

Proficient in using HP ALM and Quality Center for creating, executing, reviewing and approving requirements, test scripts, test runs, and defects.

Excellent experience in applying FDA regulations to the aspects of the Computer and Lab Systems.

Experience in validating Veeva Vault QMS and Clinical Suite, SAP ECC 6.0, Oracle EBS, LIMS, Lab Instruments, Lab Interfaces with ERP systems.

Abundant experience in generating and reviewing Computer Systems Validations CSV Deliverables according to 21 CFR Part 11 and FDA regulations for the Pharmaceutical industries

Experience in System Retirement activities according software development life cycle.

Working knowledge of GLP, GCP, GMP, GAMP 5 guidelines especially in the areas of computer or related systems

Experience in preparation and review of Validation Protocols IQ/OQ/PQ documentation, VP, VSR, SOPs, Protocol Deviation, Risk Assessment, Decommission report, Periodic Review Report.

Experience in Developing and reviewing User Requirement Specifications URS, Functional Requirements Specification FRS and Requirement Traceability Matrix RTM Documents

Technical skills:

Testing tools

HP ALM, Quality Center, JIRA X-ray

Applications

SAP, Oracle EBS, TrackWise, Veeva Vault, Master Control, Team Center(Document Management System)

Validation Deliverables

Validation Plan, Test Plan, System Criticality Assessment, RTM, URS, FRS, IQ, OQ, PQ Protocols, SOP’s/Work Instructions, Data Migration Plan, Data Migration Report, Test Defect reports, Test Reports, Validation Reports

Tools

MS Office Suite [Word, Excel, PowerPoint], MS Visio, MS Project, Share Point.

Project Experience:

Client - Thermo Fisher, Miami, FL Jan 2017 - Present

Role - Validation Engineer

Applications: Veeva Vault QMS, Oracle EBS, LIMS

Responsibilities:

Implemented ERP roll outs for Advanced Supply Chain Planning, Quality, Accounts receivables, General Ledger, BOMS, Routings, WMS, Procure to Pay process areas.

Implemented validation activities for the global implementation of Veeva Vault QMS system (CAPA, Complaints, Audits and Change Control Management modules).

Managed all buildouts and changes in Labware LIMS/eLN for the QC lab

Supported IT in the Administration of the Labware LIMS/eLN program

Managed change controls for SAP and Labware LIMS/eLN changes.

Created and maintained user accounts for Labware LIMS.

Used Agile PLM as Document repository for review and approving ERP documents such as Process, WRICEF Functional & Technical Specs, Transactions, User roles.

Developed the validation templates like Regulatory Assessment, Requirement Specs, Business Process flows, Validation Plan, Training Plan, Issues Log, Risk Assessment, Incident Reports, Change Controls, IQ Protocol/Report, OQ Protocol/Report, PQ Protocol/Report, Trace Matrix, and Validation report.

Experience in ERP Validation in compliance to FDA regulations and Company policies and procedures

Developed Validation Plan and Master Test Plans to strategize the validation approach as well as test approach in various test cycles.

Identified quality user requirements and ensured the successful implementation of ERP across all sites in the region according to global programs.

Maintained existing System & Integration Test Plan according to the Standard Operating Procedures (SOPs).

Worked on Data Migration activities from legacy system to Veeva Vault

Performed 21 CFR Part 11 assessment and Risk Assessment for Veeva Vault.

Reviewed AWS SOC reports for Veeva Systems infrastructure qualification

Authored Test Plan, PQ Protocol, Test Summary Report, RTM, Validation Summary report for Veeva Vault.

Guided the project team in completing the required validation deliverables/ activities in each phase of SDLC.

Reviewed Process flows, Requirements Documents, Configuration documents and WRICEF Custom Functional Specifications.

Guided ERP team to ensure SDLC document traceability is maintained and compliant.

Developed Validation strategy using risk-based validation approach

Developed Testing guidelines and role matrices to support testing effort to establish Good Documentation Practices (GDP).

Implemented the IQ, OQ and PQ activities

Client - Johnson and Johnson, Redwood City, CA Sep 2014 – Dec 2016

Role - Validation Engineer

Applications: Trackwise Quality Suite (QMS and Quality Docs), SAP ERP

Responsibilities:

Have experience in Validation activities for Oracle EBS system (Application Version R11i Database 10g), TrackWise

Validation experience in implementation of Trackwise Quality Suite and SAP

Validated CAPA, Complaints, NC and Audit modules in Trackwise QMS.

Implemented Author, Review, Approve, Issue, Supersede and Obsolete document lifecycle phases in Veeva Vault’s QualityDocs module.

Implemented Data Migration activities from Legacy System to Oracle ERP system

Coordinated with Business in creating Future Business Process Design documents for WMS, ASCP, GL, AR, Costing, Quality Process areas

Participated in the analysis of the User Requirements and Functional Requirements for Oracle EBS, Agile PLM and LIMS.

Created Process Flow documents for CAPA and Complaints modules in TrackWise

Reviewed and approved Functional Specifications and Technical Specifications for the interfaces developed between CDS Systems, LIMS and SAP.

Conducted Risk Assessment sessions to analyze the GxP, Business and functional impact on the user requirements with process owners, functional team and QA compliance for various ongoing projects and authored the Systems validation Risk Assessments.

Trained testing personnel on HP ALM usage.

Developed Business Requirements model, Validation Plan template, Traceability Matrix, Installation Qualification test scripts, Operation Qualification test scripts, Performance Qualification template, Validation Summary Report template with Argus

Developed Test Report, Deployment Plan and Validation Summary Report to summarize the testing and validation efforts.

Reviewed and approved Requirements in ALM

Reviewed and approved UAT test scripts in Test Plan and Test lab modules of ALM before and after execution respectively.

Reviewed and closed defects for the testing in ALM.

Prepared Deviation Reports, Deviation Logs for the various errors occurred during the testing phase of SDLC.

Prepared and executed validation protocols (IQ, OQ and PQ).

Involved in all phases of SDLC for V-type, Waterfall and sprints for Agile methodologies

Followed standard, measurable Gateway Exit process to ensure readiness of the team and for the project to proceed to next gateway check point.

Developed SOPs for Formal testing and 21 CFR Part 11 Assessment.

Updated existing Validation and Quality Management Systems SOP to reflect both project and system level documentation and Roles and Responsibilities.

Developed/Maintained the Requirements Traceability Matrix (RTM).

Client - Karthikeya Drugs & Pharmaceuticals Pvt Ltd - India Jul 2012– Aug 2014

Role - Validation Analyst

Applications – SAP and Labware LIMS

Responsibilities:

Performed Validation Testing on the application in accordance with 21 CFR Part 11.

Implemented and developed a standard process for using Electronic Signatures on all electronic-document transfers using the 21 CFR part 11 standards.

Developed the Validation Summary Report which summarizes the validation activities that were performed for the LIMS application.

Responsible for carrying out Validation activities for LIMS

Used Documentum Application for reviewing and uploading the Validation documents.

Ensured compliance with all applicable GxP regulations, policies and procedures related to Information Technology and computer systems

Involved in all testing activities including IQ, OQ and PQ using HP Quality Center

Responsible for ensuring the compliance of GAMP and FDA regulations.

Maintained existing System & Integration Test Plan according to the Standard Operating Procedures (SOPs) and VSD.

Involved in evaluating the 21CFR part 11 requirements and creating a check matrix for the same.

Involved in User meetings, Design sessions to capture the System Requirements and documented in System Requirement Specification (SRS) including interface requirements with other systems.

Developed and reviewed URS, FRS, Test Plan and Test Scripts.

Prepared/Executed IQ, OQ, PQ/UAT Test Plans, Test Scripts and Test Summary Reports.

Created Regulatory Assessments, Risk Assessments, 21 CFR Part 11 Assessments Reports.

Developed/Maintained the Requirements Traceability Matrix (RTM).

Maintained Training Logs and Incident/ Test Case Assignment logs.

Coordinated with Business and Technical folks in developing a rationale for unresolved Defects.

Semitron Medical Devices, India (InternShip) Mar 2011 – Jun 2011

Intern

Assisted Validation Testing on the application in accordance with 21 CFR Part 11.

Develop and execute Test scripts.

Assisted in performing process qualification for new equipment and new technologies.

Authored validation protocols and engineering studies.

Developed Requirements Traceability Matrices.

Developed Validation Summary Reports.

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