SUMMARY:

• Professional experience of 27 years with around 17 years of SAP Functional/ Business Analysis/ Computer System Validation/ Quality Assurance experience.
• Experienced in Global SAP Confidential / SQA involving multiple plants and countries.
• Experienced in Pharmaceutical, Bio - Technology, Medical Device, Process, Manufacturing, Distribution, Engineering, and Product Development industries.

TECHNICAL SKILLS:

SAP: OTC, PTP, PP-PI, PM, QM, IM, WM, FI, CO, HR, EH& S, CRM (SFA), SRM, MDM, GRC

Track & Trace: TraceLink, Axway

Computer System Validation & Quality Assurance: Confidential / SQA/ SDLC/ Change Control/ GAMP 5/ cGMP/ GDP/ GMP Assessment/ Risk Assessment/ 21 CFR Part 11/ Part 820/ VMP/ VSR/ URS/ Confidential / OQ/ PQ/ Testing/ Deviation Resolution, Security, SOP, Configuration Documentation

PROFESSIONAL EXPERIENCE:

Confidential

Senior Consultant

Responsibilities:

• Authored Validation Master Plan, URS, RA, TM, PQ and Summary Reports.
• Authored and Executed PQ test scripts, including Security.

Confidential, Sunnyvale, CA

SAP Validation QA Consultant

Responsibilities:

• Authored User Requirements and Performed Risk Assessments.
• Created OQ/ PQ test protocols/ ­­­scripts
• Identified defects from OQ/ PQ executions and resolved the same.

Confidential

SAP Business Analyst/ Confidential Testing Lead

Responsibilities:

• Single Point of Contact for OQ/PQ test script authoring and execution related tasks.
• Interviewed business users and authored User Requirement Specifications (URS).
• Authored and reviewed Functional Requirement Specifications ( Confidential .
• Performed GMP and Risk Assessments.

Confidential, St. Paul, MN

SAP Validation Lead

Responsibilities:

• Led URS, Confidential and Test Scripts authoring and execution.
• Performed GMP and Risk Assessments.
• Reviewed and approved pre & post execution of OQ/ PQ test scripts.

Confidential, Lake Forest, IL

SAP Testing Manager

Responsibilities:

• Managed and supported OQ/ PQ test script executions to meet the expected quality standards in HP ALM (HPQC)

Confidential, West Palm Beach, FL

SAP Validation/ SQA Lead

Responsibilities:

• Authored Validation Master Plan (VMP).
• Interviewed users and authored User Requirement Specifications for OTC, PTP, WM, QM, PP and PM modules.
• Authored and executed OQ/ PQ test scripts for OTC, PTP, WM, PM, PP and QM modules.

Confidential, Fort Washington, PA

Senior SAP SQA Consultant

Responsibilities:

• Reviewed pre and post execution of SAP QM integration test scripts in HP ALM.

Confidential, South San Francisco, CA

Senior SAP SQA Consultant

Responsibilities:

• Reviewed and approved pre & post execution of test scripts for various projects including ECC 6.0 upgrade and Maintenance & Enhancements in HP ALM.
• Reviewed and approved URS/ Confidential / FS documentation.
• Conducted ‘Risk Assessment’ meetings, as part of change control.
• Maintained Trace Matrix as part of change control activities.

Confidential, San Diego, CA

SAP Functional Validation Consultant

Responsibilities:

• Authored OQ test scripts for SAP CRM Security, ‘Role-based Access Control ( Confidential )’.
• Reviewed OQ test scripts for SAP QM - Quality Notification security requirements.

Confidential, Brooklyn Park, MN

SAP Validation Lead

Responsibilities:

• Authored test scripts for SAP PM/ QM/ PTP/PP-PI modules.
• Created Traceability Matrix (RTM).
• Reviewed executed IQP/ OQP/ PQP documents, as a part of change control.
• Authored IQP and PQP documents for SAP Disaster Recovery and Standby system.

Confidential, Warsaw, IN

SAP Validation/ QA Lead

Responsibilities:

• Reviewed and approved Validation Master Plan (VMP).
• Performed GMP assessments on OTC/ PTP business processes.
• Reviewed and supported OQ test scripts executions for SAP OTC/ PTP/ MDM/ FI modules.

Confidential, Irvine, CA

SAP Functional/ Validation Consultant

Responsibilities:

• Interviewed business team/ users and authored URS and Confidential documents.
• Participated in harmonization sessions with plants located in USA, Ireland and Brazil.
• Performed Risk Assessments.
• Authored and executed OQ/ PQ test scripts.
• Authored URS and Confidential for 21 CFR Part 11 Electronic Records & Electronic Signatures requirements.

Confidential, Hauppauge, NY

SAP Quality Assurance/ Validation Consultant

Responsibilities:

• Analyzed and documented the gaps between System Design Documentation and SAP CRM - SFA Administration and Mobile applications.
• Executed PQ for SAP CRM-SFA, Admin and Mobile applications.

Confidential, Fremont, CA

SAP Consultant

Responsibilities:

• Authored URS and Confidential documentation based on business process requirements.
• Authored and executed OQ Test Scripts.
• Reviewed URS, Confidential and OQTP documentation in accordance with traceability matrix.

Confidential, Corona, CA

SAP SQA/ Validation Lead

Responsibilities:

• Reviewed and approved User Requirement Specifications (URS), Functional Requirement Specifications ( Confidential ), Custom Functional Specifications (CFS), OQ and PQ Test protocols.
• Performed GMP & Risk Assessments.
• Reviewed and approved Traceability Matrix.
• Provided QA support during OQ/ PQ executions.
• Created Configuration Documentation for Plant Maintenance module.
• Provided QA support during Cut-over and Data Conversion activities.
• Reviewed OQ/ PQ test scripts for ' Confidential ' SFA software (PDMA), mobile devices.