SUMMARY

• Over Twenty - Four years of experience in Information Technology with emphasis on Computer Systems Validation (CSV) and Software Quality Assurance (SQA), Software Development and Testing, Software Verification & Validation, FDA Regulations and Technical Documentation in Pharmaceutical, Biotech and Medical Device Industry.
• Strong experience in 21 CFR Part 11, Part 50, Part 58, Part 820, Quality System Regulation (QSR), GxP, GAMP, SDLC Methodology and CAPA (Corrective and Preventive Action).
• Strong experience in performing System Risk Assessment along with mitigation of risk for Computer System Validation.
• Strong experience to support various Change Controls, Impact assessment for Computer Systems, Laboratory Instruments, Laboratory Equipment for new Implementations, and Upgrades.
• Current in-depth experience in investigation and evaluation of application, process and data integrity deviations, ensuring that appropriate actions are in place to address root cause.
• Strong experience in writing Closure Summary/summary reports along with proposed resolutions and remediations in GxP operations.
• Strong experience in testing and supporting of End to End Backup and Restore, Disaster Recovery of GxP Systems.
• Experience in validating Laboratory Information Management Systems (LIMS), Clinical Trail Management Systems (CTMS), Electronic Quality Data Management System (EQDMS).
• Extensive knowledge of business process and workflows associated with the GLP, GCP, GMP systems used in Clinical, Non-Clinical, Regulatory, Quality, Drug Discovery areas.
• Strong experience in validating GLP applications such as Watson LIMS, Sapphire LIMS, SharePoint, PKS and associated interfaces.
• Strong experience in validating ERP software like SAP R/3 ERP, Oracle ERP System and JD Edwards
• Strong experience in developing test Strategy, Test plans and Test scripts and analyzing bugs in client server, multi-tier and web Applications and cloud-based SaaS (Software as a Service) applications.
• Strong Experience in Qualifying Infrastructure.
• Excellent communication and presentation skills.
• Excellent organizational skills, capable of multi-tasking.

TECHNICAL SKILLS

GLP Systems: Watson LIMSv7.4.1, Lab vantage Sapphire LIMS, WinNonlin 5.2.1, NONMEM, SigmaPlot, PKS 3.1, Watson Custom Reports, MicroPlate Readers (Tecan and MSD Sector), Tecan ELISA station.

GCP Systems: Clinical Trail Management System(CTMS)-Trail works, Clinical Data Management System(CDMS)-Medidata Rave, Veeva Vault eTMF, Phlexeview eTMF, Veeva MedComm, PromoMats, and Vault Portal.

Quality Document Management: Veeva Vault, MS SharePoint, Livelink, Documentum and TrackWise.

GMP systems: SAP R/3 4.6 C/D, JDE One World, Oracle EBS / Oracle Fusion ERP System

Testing tools: Octane, HP ALM, Win Runner, Load Runner, and Test Director.

Reports: Business Objects (BO) Reports, Crystal Reports

Microsoft office/Analytic Tools: MS-Word, MS-Excel, MS Project, Tableu

Design Tools: Rational Rose and Visio.

Testing Tools: Rational Clear Quest, Mercury Interactive (Win Runner 5.0, Test Director, Load Runner), PVCS Version Manager, PVCS Tracker

Paperless Validation: HP ALM (Application lifecycle Management), Val Genesis

Database: Oracle7.x/8i, MS-SQL Server 6.5/7.0/2000 , DB2 and MS-Access.

GUI: Visual Basic 6.0/5.0 and VC++

Operating System: MS-Windows XP/Vista/2000/NT/7/8, MAC OS X, UNIX IBM-AIX and Linux

Application Servers/Web Servers: Windows Server2007, MS Internet Information Server (IIS), Weblogic Server, Apache, Citrix Metaframe Server

Languages: C, C++, C#, SQL, PL/SQL

Scripting: Perl, java

Web Technologies: C#. Net, Asp.Net, VB.Net

PROFESSIONAL EXPERIENCE

Confidential

Senior Business Analyst/ Validation Lead

Responsibilities:

• Performed business analysis within GMP Manufacturing and Quality business technology area, supporting global Supply Chain, Manufacturing, Quality to implementing Oracle Fusion ERP Supply Chain and Manufacturing System /RF SMART Mobile Warehouse solutions.
• Responsible for overseeing activities for gathering, analyzing and prioritizing requirements of Supply Chain, Manufacturing and Warehouse Mobile modules in Oracle Fusion ERP System.
• Coordinated with Process Owners, System Owner and Quality n gathering and completing the Impact Assessments of the New Implementation and existing impacted systems and integrations.
• Worked on Change Plan and Change actions to manage and track the change operations across cross function teams of Supply Chain, Manufacturing, Quality Control, Quality Assurance, Training, and Information Technology.
• Authored Master Validation Plan to define the Validation approach using risk-based approach to align with Audentes Internal procedures and policies.
• Managed the Change Control using Veeva QMS and Prepared Change Control documentation.
• Authored Qualification Protocol(s) (IQ, OQ and PQ) and revised existing documentation. Performed reviews on various documentation and provided feedback using Document Management System.
• Involved in generating Test procedures, perform dry runs of the new implementation.
• Reviewed and approved Vendor Technical Documentation like Design Specifications, Configuration Specification of Oracle Finance, SCM, Manufacturing, Purchasing and Warehouse modules and provide feedback to align Validation Deliverables (Installation Qualification).
• Mange the Vendor on coordinating the development deliverables, environment setups and Test user accounts and Data setup for Integration/Regression Testing/UAT.
• Provide Validation Training to the End Users on performing User Acceptance Testing, Performance Qualification.
• Authored Data Migration/Conversion Plan to address the validation of Data Migration/Data Conversion from Oracle Production.
• Validation and support of Quarterly Releases under Change Control.
• Authored Summary Reports and Traceability Matrix
• Worked with Vendor and implementation team to Prepare system Post live performance Evaluation methods and metrics.
• Managed electronic routing of Validation documentation using Master Control Document Management System.
• Assisted with the team in quality systems deviations, investigations, and CAPA resolutions.

Confidential

Sr Validation Lead/Sr. CSV Consultant

Responsibilities:

• Support and Manage validation of Veeva Vault Quality Document Management System replacing GDocs System including System integrations and Data Migration assuring the thoroughness of validation while adhering Gilead guidelines and standards and Quality and compliance expectations.
• Author Data Migration Plan, Validation Protocols (Interface IQ, OQ and PQ).
• Analyze and prepare Metrics on Validation activities to the Project Team.
• Manage the execution of IQ, OQ, PQ and Data Migration test scripts and assisted in resolving the Discrepancies and issues during execution.
• Prepared Data Migration Summary Report, Validation Summary reports of the Validation and Production executions.
• Assisted in support of hyper care and Change controls.
• Regulatory Information Systems Validation and Support:
• As a Validation Lead to support validation activities for projects involving GxP critical computer systems like Regulated Document Management System (RDMS), LIQUENT Submission Management System (SMS), and SharePoint Label Change Tracker System (LCT) used in Regulatory Affairs group and QDMS system in Gilead IT and PDM to ensure quality and compliance are built into the system.
• Provided validation approach and guidance on implementing new Computer Systems or changes to the existing GxP systems in multiple Projects within IT QSC.
• Responsible to ensure quality validation processes are executed as defined by procedures within IT QSC and Regulated Compliance group.
• Prepared Change Control documentation, Validation Plan, Qualification Protocol(s) (IQ, OQ and PQ), Test Plans, System Suitability tests, Risk Assessments, Reports, Summary Reports and Traceability Matrix for new system implementations, existing system upgrades including database upgrade and data migration, and various bug fixes and configuration changes.
• Supported End to End testing of Disaster Recovery, backup and recovery process for the RIS systems.
• Involved with Vendor, System Manager and Technical team to gather functional specifications and Design Specifications
• Responsible to prepare risk-based approach for validation, including testing, documentation and verification activities, with appropriate justification of the approach.
• Managed electronic routing of review and approval of documentation using GDOCS, GTrack and SharePoint ensuring compliance to current procedure for e-approval.
• Assisted with the Quality Team on system and Data integrity deviation investigations and CAPA resolutions.
• Involved in tracking all testing and issues/incidents and manage deviations.
• Analyze and prepare metrics of Validation.
• Worked with Vendor and implementation team to Prepare system Post live performance Evaluation methods and metrics.
• Provided validation Support to retire legacy systems with in RIS.
• Work with core team to adopt the paperless validation process using HP-ALM.