SUMMARY

• Certified QA & ITIL professional with over Eighteen years of Computer System Validation, Business Quality Assurance, Project Management, Regulatory Audit and Compliance experience combined with a unique blend of business analysis, management and technical competency gained in innovative global pharmaceutical and bio - technology companies.
• A detail oriented self-starter and a team player who has the ability to produce quality work on time in a fast-paced, deadline-driven environment and capable of managing multiple projects simultaneously.
• Strong project management and analytical decision making skills with a successful track record in Change Management, Enterprise Resource Planning, Enterprise Content Management, Clinical Data Management, Remediation and Revalidation, Sales Force Automation, Corrective Action Preventive Action (CAPA) Management, Track wise, ARGUS, LIMS, Process Improvement, Operational/Performance Readiness Analysis, Strategy, Business and Resource Management, Regulatory Compliance, audit/response,GAMP4, GAMP5 and Quality Assurance.
• Accomplished several Major and Minor Validation life cycles.
• Good understanding of GAMP, GxP regulations
• Experienced in complete Software Test Methodologies, Service Management and Quality system tools.
• Experience in working complex system dependencies and identify situations environment
• Experience in facilitating testing meetings as well as status meetings with key stakeholders. Identify, communicate and manage test related issues and risks with downstream dependencies
• Experience in designing and developing system, functional and Integration test scripts
• Experience in Test Strategy, Test Plan, execution and resource estimations, test suite design, Testing Management, Defect Management and Testing Status Reports.
• Authored several business, User and functional requirements to identify test scenarios and develop Test scripts steps
• Collaborated with various functional leads, stakeholders for review and approval of various documents
• Acted as single point of contact between development team, functional, Basis and testers
• Assist business users in defining user acceptance testing
• Conducted several trainings to end users and acted as SME
• Experience in implementing several automation testing tools like Selenium, HP ALM & Worksoft
• Worked on several SAP Upgrade projects
• Team Player with the ability to manage multiple tasks in a deadline driven environment

TECHNICAL SKILLS

Operating System: UNIX (Solaris), Ms-Windows XP/2000/NT, and Linux 2.4, MS-DOS.

Languages: TSL, 4TEST, C, C++, Java 2.0, SQL, PL/SQL

Laboratory: Watson LIMS, Oracle clinical, PKDMS

Clinical Software: CTMS, EDC, IVRS, ePRO, Oracle clinical

ERP: SAP R/3 (MM,SD,PM,PP,QM),MES, Workflow, SAP CRM, JD Edward

Regulatory Tools: GAMP 5, 21 CFR PART 11, CGMP, Risk Assessment, SOX, JSOX, Risk Management

PROFESSIONAL EXPERIENCE

Confidential

Project Quality Manager / Principal

Responsibilities:

• Author several key validation deliverables as formalized in the Project Documentation List (PDL). Review compliance aspects of all other project document deliverables as formalized in the PDL.
• Escalate project quality issues to project team & program Project Quality Manager.
• Along with the project manager, prepare and reply to project-related Computer System Validation (CSV) or Information Security Risk Management (ISRM) audits, assessments or inspections where applicable.
• Support Project Manager (PM) in risk management activities. Escalate to the PM / PMO identified compliance and information security related gaps and risks as they appear to enable timely risk management.
• Participate in Validation Life Cycle (VLC) planning, implementation and documentation.
• Facililated regular ISRM alignment on SCOPING of all ISRM controls

Confidential

Project Quality Manager / Principal

Responsibilities:

• Author key validation deliverables like Qualification Plan, FS, Cutover plan & Qualification Report.
• Reviewed all testing deliverables related to this project.
• Authored PCMA assessment for the application

Project Quality Manager / Principal

Responsibilities:

• Authored key validation deliverables like Validation Plan, PCMA, OQ and PQ test plan,Cutover plan & Validation Report.
• Performed functional and project risk assessment
• QA Oversighted team on GXP and SOX
• Authored PCMA assessment and external CMAAS assessment for the application
• Lead a team of 4 off shore support
• Reviewed URS/FS, OQ and PQ documents

Confidential, Sinking Springs, PA

Project Quality Manager / Principal

Responsibilities:

• Author key validation deliverables as formalized in the Project Documentation List (PDL). Review compliance aspects of all other project document deliverables as formalized in the PDL.
• Escalate project quality issues to project team & program Project Quality Manager.
• Along with the project manager, prepare and reply to project-related Computer System Validation (CSV) or Information Security Risk Management (ISRM) audits, assessments or inspections where applicable.
• Support Project Manager (PM) in risk management activities. Escalate to the PM / PMO identified compliance and information security related gaps and risks as they appear to enable timely risk management.
• Proactively complete all deliverables as early as is reasonably possible, bringing forward deliverables where possible to prevent back loading and potential impact to program timelines.
• Participate and actively engage in weekly meetings with project stakeholders (PM / PMO) to provide updates on status of delivery of owned deliverables and to identify potential risks associated with late delivery of documents to PQM service for review.
• Lead PQM to train project team on good testing practices and good documentation practices.
• Ensure program is following project management methodology and assess impact of deviations. To reach out to program lead PQM and ensure proper risk management is applied when changes to agreed methodology are requested by project.
• Verify procedural deviations and support preparation of deviation reports.
• Along with the project manager, participate and document project handover to operations; PQM to OQM transition.
• Review system change requests in Change Request Manager (CHARM).
• Ensure traceability is verified throughout the project (PQ testing results are traceable back to business process)
• Verify that end users are identified as being properly trained prior to provision of access.
• Periodic status reporting to the program PQM and coordinating with support PQMs (rollout PQM is responsible for overall PQM service delivery for particular rollout)
• Facilitate regular alignment meetings with eCompliance.
• Participate in Validation Life Cycle (VLC) planning, implementation and documentation.

Confidential

Sr GXP Consultant

Responsibilities:

• Coordinated with various stakeholders during blue printing phase
• Interacted with third party provider on various issues
• Performed risk assessments for various systems
• Developed and executed of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, Integration, User Acceptance testing, Validation Summary Report).
• Reviewed documents related to SAP work soft tool
• Created test cases/scripts for functional and UAT testing
• Tested and support applications on multiple environments simultaneously like development and QA
• Coordinated team in designing and developing the business processes
• Actively participated in defect resolutions
• Interacted with business users, gather and analyze software requirements to prepare FRS with Quality standards using the tool “CERTIFY Process Capture”

Environment: WORKSOFT CERTIFY 10.0.0.955 , CERTIFY Dashboard, SAP ECC 6.0 (MM, WM, HR, SF, FICO, QM, SD, BW-HANA, IM), HP ALM, JIRA, GAMP 5, FDA, 21 CFR part

Confidential

QA Manager

Responsibilities:

• Configure the integration of SAP work soft with HP ALM
• Developed and executed of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, Integration, User Acceptance testing, Validation Summary Report).
• Reviewed documents related to SAP work soft tool
• Created test cases/scripts for functional and UAT testing
• Tested and support applications on multiple environments simultaneously like development and QA
• Coordinated team in designing and developing the business processes
• Actively participated in defect resolutions
• Interacted with business users, gather and analyze software requirements to prepare FRS with Quality standards using the tool “CERTIFY Process Capture”

Environment: WORKSOFT CERTIFY 10.0.0.955 , CERTIFY Dashboard, SAP ECC 6.0 (MM, WM, HR, SF, FICO, QM, SD, BW-HANA, IM), HP ALM, JIRA, GAMP 5, FDA, 21 CFR part

Confidential

QA Lead

Responsibilities:

• Wrote test scripts related to shop floor management, Electronic Batch Record Management
• Developed and executed of all applicable system life cycle deliverables (e.g., URS, SRS, FRS, DDS, RTM, Unit, Integration, User Acceptance testing, Delta V, FAT, SAT, Validation Planning, IQ, OQ, PQ, Final Validation Summary Report).
• Performed testing for TCP/IP from bottom level to Top level
• Performed regression testing
• Developed test scripts related to weigh and dispense.
• Daily interacted with Central American business users ( Brazil, Argentina, Portuguese, Guatemala, Panama, Dominican Republic Costa Rica, Honduras, El Salvador) during UAT execution
• Developed test scripts related logistics and transport management system for Syncade interface
• Developed Test summary report for MES integration
• Reviewed all Global and local Policies and SOP’s
• Reviewed and approved Risk/Impact analysis
• Works closely with cross-functional departments and business process personnel across the organization.

Environment: SAP ECC 6.0 (MM, HR, WM, FICO, QM, SD,BW-HANA, IM, SOLMAN, Test Management), ARGUS, GAMP 5, FDA, 21 CFR part 11 Syncade Emerson 5.3, SAP CHARM, HP ALM v 11.00, SQL, WIN 2k2, Sun

Confidential

QA lead

Responsibilities:

• Perform GAP Analysis for various SOPs
• Developed documents related to SAP Upgrade
• Wrote requirements related to upstream (Planning) and downstream (Control) integration systems for MES
• Wrote VAL Plan and Summary report for various EDI’s which are integrated to MES
• Reviewed various business processes related to Shop floor management, Genealogy, Nonconformance, return Managements
• Wrote UAT/E2E test scripts for Syncade and JDE integration
• Reviewed and approved Risk/Impact analysis
• Worked as Track Wise SME and trainer for IT team
• Developed and reviewed all validation deliverables like Val plan, Design specs, URS, FRS IQ, OQ Protocol, final Val summary report.
• Works closely with cross-functional departments and business process personnel across the organization.

Environment: SAP ECC 7.0, Trackwise, ARGUS, HP ALM v 11.00, WIN 2k2, Sun

Confidential, PA

HP ALM Test Lead

Responsibilities:

• Managing testing effort for implementation of ARUS/AER
• Lead a team of 4 members
• Reviewed and approved Risk/Impact analysis
• Wrote Val plan, Design specs, URS, FRS IQ, OQ Protocol, final Val summary report.
• Reviewed defects in data migration testing as a Quality resource
• Good knowledge in European regulatory guidelines and annexures 11
• Works closely with cross-functional departments and business process personnel across the organization.

Environment: HP ALM 11.0, Archive manager, SQL, WIN 2k2, Sun

Confidential

Validation/ QA Analyst

Responsibilities:

• Involved in meetings with different Business users functional & technical team
• Analyzed the discrepancies between the system and FRS
• Developed OQ scripts for various modules
• Analysis various modules and business processes to build test scripts
• Involved in formal test execution in HPQC Test Lab module
• Developed Integration scripts

Environment: SAP CHARM, SOLMAN, HPQC 10.00, MS office

Confidential, VT

ERP CSV/ QA Lead

Responsibilities:

• Managing validation effort for retrospective validation of Navision application
• Guiding Confidential on best practices in Compliance / regulatory Process flow
• Developed retrospective validation deliverables for NAV application
• Actively monitors and adheres to all guidelines around the creation, update, review, approval and periodic review of SOPs.
• Wrote Retrospective deliverables like Validation plan, Risk assessment, IQ/OQ /PQ test plan & summary reports
• Reviewed and approved Risk/Impact analysis
• Wrote Data migration Plan for all MES interfaces
• Reviewed data migration test scripts both Pre-Post scripts
• Reviewed defects in data migration testing as a Quality resource
• Works closely with cross-functional departments and business process personnel across the organization.
• Successfully completed all Validation effort for initial deployment

Environment: MS Dynamics NAV and ARGUS, MRP, SQL, WIN 2k2, Sun

Confidential, CA

SAP QA Lead

Responsibilities:

• Managing QA effort for new implementation of SAP system for BIORAD along with IBM Implementation partners
• Daily Interaction with Consultants, SME, Developers, functional
• Lead a team of 3 members
• Guiding team on best practices in Compliance / regulatory Process flow
• Approving GMP & Non GMP documents in Esign HPQC
• Actively monitors and adheres to all guidelines around the creation, update, review, approval and periodic review of SOPs.
• Wrote Validation plan, OQ /PQ test plan & summary reports
• Reviewed and approved Risk/Impact analysis
• Wrote various business processes related to MES integration.
• Wrote data migration test scripts both Pre-Post scripts
• Wrote scripts on Trackwise Parent-Child relations
• Reviewed defects in data migration testing as a Quality resource
• Works closely with cross-functional departments and business process personnel to resolve complex Quality issues relating to documentation and defined Quality System Elements.
• Approving & reviewing defects in HP service center
• Approving Test scripts in QC center
• Managing OQ/PQ Defects
• Wrote SOP’s for Infrastructure, Change management
• Successfully completed all Validation effort for initial deployment

Environment: SAP ECC 6.0 (MM, MRP, PM, FICO, PP,QM, SD,SOLMAN, HANA, Work soft, GRC, HP Quality Center version 10.00, ALM v 11.00, SQL, WIN 2k2, Sun

Confidential

SAP CSV/QA Lead

Responsibilities:

• Change the culture of the team during the implementation of Change Management Process for SAP BI team at Confidential
• Managing Validation effort for complete SAP BI Team which consists of around 70 consultants
• Daily Interaction with Consultants, Senior executives, Business on BI related compliance
• Guiding and brainstorming BI Team how to use best practices in Compliance / regulatory Process flow
• Approving GMP & Non GMP documents in GXPharma
• Involved in Release 6 & 7 for European
• Worked on Remediation activities on Various changes
• Reviewed and approved Risk/Impact analysis
• Wrote Test scripts for various modules in SAP R/3 by using HPQC
• Executed various types of scripts(OQ,PQ) in HPQC
• Approving /Review Service request/Change controls in HP service center
• Reviewed and approved Data migration
• Approving Test scripts in QC center
• Managing BI Defect
• Worked on Interface between Trackwise and SAP workflow
• Tested various crystal reports for parent child, single, multi notification
• Successfully completed all BI Validation effort for R1R2 & R3 deployments
• Reviewed Pre & post execution OQ scripts
• Reviewed and approved deviations
• Maintain BI metrics, SCR Metrics
• Worked on Val 7489 (FRS document which consists of around 1000 pages for SAP implementation) for all releases

Environment: SAP ECC 6.0 (MM, PM, FICO, BW- HANA,SD,SOLMAN), Syncade MES, GXPharma, HP service center, HP Quality Center version 10.00, ALM v 11.00, SQL, WIN 2k2, Sun

Confidential

SAP Validation

Responsibilities:

• Wrote Validation Plan
• Wrote OQ protocol & OQ summary report
• Reviewed Pre & post execution OQ scripts
• Reviewed and approved deviations
• Wrote PQ protocol, PQ summary report, Final PQ Summary Report
• Reviewed Pre & post execution PQ scripts
• Wrote / reviewed deviations for OQ,PQ & Data migration
• Approving /Review Service request/Change controls in HP service center
• Reviewed data migration test scripts both Pre-Post scripts
• Reviewed defects in data migration testing as a Quality resource
• Develop data migration plan, Interim Summary Report & Data migration Final summary report
• Analyzed/tested various SAP transports in development/Quality/production environment
• Worked as SME for end user training
• Interacted with different Business users, developers and Quality assurance team

Environment: SAP ECC 5.0 (QM, MM, PM, FICO, SD), Trackwise 6.0 CAPA, Oracle, IBM-SCORE, FDA, 21 CFR Part 11, SQL, HP QC v 10.00, WIN 2k2, Sun