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 risk assessment, gap analysis, Change Control process and deviation management.
• 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.
• Experience in validating Laboratory Information Management Systems (LIMS), Clinical Trail Management Systems (CTMS), Electronic Quality Data Management System (EQDMS) and vendor hosted SaaS Systems.
• Good understanding of business process and workflows associated with the GLP, GCP, GMP systems used in Life sciences, Pharma and Biotech.
• Strong experience in validating analytical equipment.
• 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.
• Experience in supporting Infrastructure Qualification.
• Excellent written and verbal communication skills.
• Excellent organizational skills, capable of multi-tasking.
• Strong experience in Google Apps(Gmail, Google Calendar,GDocs and GDrive) for Work applications.

TECHNICAL SKILLS

GLP Systems: Watson LIMSv7.4.1, Labvantage 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: MS-Word, MS-Excel and Ms Project.

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, 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 Validation Lead

Responsibilities:

• As a Validation Lead, I have managed Validation Workstream for implementing Oracle Fusion ERP Manufacturing System and RF SMART Mobile Warehouse solutions.
• 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.
• Coordinated with Process Owners, System Owner and Quality n 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 Manufacturing, Quality Control, Quality Assurance, Training, and Information Technology.
• Facilitated with Business Process owners in gathering and reviewing the business Processes and requirements for Supply Chain, Manufacturing, and Warehouse Mobile solutions.
• Authored new Qualification Protocol(s) (IQ, OQ and PQ) and also revised existing documentation as per the Validation Plan. 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.
• 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:

• 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 with in IT QSC.
• Responsible to ensure quality validation processes are executed as defined by procedures with in IT QSC and Regulated Compliance group.
• Facilitated and supported validation trainings, change control processes, periodic review of validated systems.
• 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.
• Involved with business to gather user requirements
• Involved with Vendor, System Manager and Technical team to gather functional specifications and Design Specifications
• Involved in Validating Data Analytical Reports using Cognos and SQL Queries and views.
• 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 team in quality systems deviations, investigations, and CAPA resolutions.
• Supported and managed the execution of validation testing including IQ, OQ, PQ and UAT.
• Involved in tracking all testing and issues/incidents and manage deviations.
• Worked with business, quality, and technical teams throughout project in generation of project / validation deliverables.
• Worked with Vendor and implementation team to Prepare system Post live performance Evaluation methods and metrics.
• Prepared validation documentation package for archival.
• Provided validation Support to retire legacy systems with in RIS.
• Work with core team to adopt the paperless validation process using HP-ALM.

Validation Lead

Confidential

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.
• Mentor and led a team of 6 consultants(Onsite and off-shore) to assist on validation and data migration deliverables.
• Author Data Migration Plan, Validation Protocols (Interface OQ/PQ).
• Manage the execution of IQ, OQ, PQ and Data Migration test scripts and assisted in resolving the Discrepancies and issues during execution.
• Prepared Summary reports of the executions and assisted in support of hyper care and Change controls.