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.

PROFESSIONAL EXPERIENCE

Confidential, Miami, FL

Validation Engineer

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

Confidential

Validation Engineer

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).