Sudhir Panjwani 913-777-4620: Professional Summary

Sudhir Panjwani
[email protected]
913-777-4620
PROFESSIONAL SUMMARY:
 Over 7 years of experience as an IT Compliance professional in Life sciences industry with focused experience in Software
Quality Assurance / Validation.
 Strong knowledge on Pharmaceutical/Medical device regulations 21 CFR Part 820, 210, 211 and Annex 11.
 Excellent experience as IT QA point person on Documentum, Manufacturing Execution System (MES), SAP, Veeva Vault,
TrackWise, Laboratory Information Management System (LIMS), Electronic Document Management System (EDMS), Data
Migration and Adverse Event Reporting System (AERS).
 Hands on experience providing active Quality oversight for validating a wide variety of systems including Enterprise IT,
Infrastructure, Software Tools and Excel Spreadsheets.
 Excellent experience in authoring, reviewing, updating and approving IQ/OQ/PQ test protocols and test cases.
 Hands-on experience in conducting Pre-execution and Post-execution reviews for IQ/OQ/PQ/Data Migration test cases.
 Excellent working knowledge of Good Documentation Practices – this includes ensuring Good Documentation Practices are
followed while drafting and executing IQ/OQ/PQ Test Cases.
 Excellent experience in Quality Metrics.
 First rate experience in reviewing/updating the following Validation deliverables - IQ/OQ/PQ test protocols/test scripts, Test
Defects, Validation Plans, Infrastructure Qualification Plans, Risk Assessments, Requirement Specifications, Qualification
Protocols, Data Migration Plans, Trace Matrices and Validation/Qualification Summary Reports
 Proven track record in reviewing/updating SOPs, Work Instructions, User Manuals and Training Manuals.
 Hands on experience in the implementation of 21 CFR Part 11 rules (Electronic Records, Electronic Signatures, Audit Trails and
Security).
 Extensive experience in FDA regulated environment with good understanding of cGxP (GMP, GDP, GCP and GLP).
 Knowledge in various types of testing such as Functional Testing, Integration Testing, positive Testing, negative Testing,
Regression Testing, Front end Testing, GUI, Black box Testing, White box Testing, Load/Stress Testing, Performance Testing and
User Acceptance Testing.
 Experience in Reviewing/Writing/Updating SOPs and training users on SOPs and quality methodologies.
 Excellent experience in reporting Quality Metrics.
 Expertise in drafting, maintaining and generating software defect reports.
 Capable of mentoring small teams, detail oriented, good communication skills and ability to work independently or as a team
player.
PROFESSIONAL EXPERIENCE
NovoBiotic Pharmaceuticals, MA Jul 2019 – Present

ROLE: SQA Analyst
Systems: Windchill PLM, Salesforce
Responsibilities:
 Responsible for ensuring project adherence to J & J processes and standards.
 Guided project teams on best practices across all SDLC processes to ensure consistent use of process assets.
 Ensured metrics are collected, validated and analyzed to identify systemic issues and their business impact and recommend
actions for strategic enhancements; aiding continuous improvement of the project.
 Ensured defects are managed correctly and that the information captured is used to analyze the process that caused the defects
and identify future preventative actions
 Conducted Assessments to measure the overall health of the project and mitigate any project risks from sprint to sprint/ phase
to phase.
 Ensured that bi-directional traceability analysis is maintained across the project lifecycle verifying that all elements are linked to
the approved specifications and test scenarios to ensure full test coverage of the application.
 Collaborated with project teams to develop and review CSV Risk assessments and Business Impact assessments.
 Reviewed and approved Validation/Compliance Analysis documents.
 Authored and approved Validation Plans & Validation Summary Reports.
 Reviewed and approved URS/FRS, Sprint Backlogs, Risk Assessments, Traceability Matrices, UAT Protocols, Test Scripts, and
Defect Reports.
 Approved Data Conversion/Migration protocols, scripts and test reports for GxP UAT and Production load for GxP systems.
 Conducted Stage Gate Assessments to verify that artifacts & activities adhere to the defined processes and standards.
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Sudhir Panjwani
[email protected]
913-777-4620
 Collaborated with stakeholders to ensure that all deliverables are met, reviewed and signed off in accordance to JNJ’s SDLC
framework.
Client: West Ward Pharma, NJ Feb 2017 – Jun 2019

Role: SQA Analyst
Systems: SAP ECC 6.0, EDMS
Responsibilities:
 As SQA Analyst worked with clients, vendors, IT and business groups to successfully manage timelines and objectives for SAP
and D2 for Lifesciences (Documentum)
 Implemented Procedure Approval, Change Request, Document Periodic Review, Document Withdrawal, Labeling and Marketing
workflows in Documentum
 Responsible for reviewing and approving Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification
(OQ), Performance Qualification (PQ) and Data Migration Plan (DMP)
 Configured and validated different lab system software according to User and CFR Part 11 requirements.
 Document functional requirement specifications and prepare use case documents for functionalities in each release.
 Constant review of standard operations (application functionalities) code for optimizing execution time.
 Reviewed and approved URS, FRS, Risk assessment, Regulatory assessment,21 CFR part 11 assessments, GAP analysis document,
Test Deviation Report, Validation plans, Validation reports, IQ/OQ/PQ protocols, Data Migration Protocols, Change controls and
Problem reports.
 Responsible for reviewing and approving all the validation deliverables
 Reviewed and approved FDS and TDS for custom objects (RICEWF objects)
 Prepared detailed compliance reports for Installation Qualification (IQ), Operational Qualification (OQ), as well as Performance
Qualification (PQ) protocols in agreement to FDA standards.
 Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan and
Change Control Summary Report.
 Implemented change controls, release management, version control and document control.
 Extensively involved in defect tracking, reviewing, analyzing and reporting test result using Test Director.
 Tracked the validation progress through validation assessment reports.
 Participated in compliance audits of systems, general assessments, risk assessments, 21 CFR Part 11 assessments.
 Reviewed and modified existing Standard Operating Procedures (SOP’s) for document management system, System
Administration, Change Control Procedures and Testing SOP’s.
 Monitor any deviation, address such to management team for Change Control.
 Performed regulatory risk analysis and remediation plans for global compliant system.
 Created Traceability Matrix to define the relationship between requirements, Design Specifications and Test Scripts.
 Reviewed and approved applicable test cases for integration test, system test and acceptance test.
 Ensured implementation of the risk management process including reporting and oversight of remediation/mitigation efforts
and monitored and reported information risk status, trends and issues.
 Reviewed and approved validation summary report to summarize and document all validation activities.
 Contribute to the overall development and maintenance of policies and procedures as related to compliance activities.
Client: Salix Pharmaceuticals, NC Oct 2014 – Jan 2017

Role: IT QA Consultant
Systems: TrackWise, AERS
Responsibilities:
 Drafted end to end Validation deliverables for AERS
 Responsible for validating CAPA and Complaints modules of TrackWise.
 Responsible for authoring CAPA and Complaints modules scripts.
 Created Process Flow documents for CAPA and Complaints modules in TrackWise
 Executed the CAPA and Complaints modules scripts.
 Authored/Executed IQ, OQ, PQ/UAT Test Plans, Test Scripts and Test Summary Reports.
 Performed role based testing in CAPA module.
 Used Documentum Application for reviewing and uploading the Validation documents.
 Ensured compliance with all applicable GxP regulations, policies and procedures related to Information Technology and
computer systems
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Sudhir Panjwani
[email protected]
913-777-4620
 Implemented the whole life cycle of QA Methodology starting from Planning, Capturing, Creating, Executing, Reporting and
Tracking the defects.
 Maintained a log of pre-production change controls in Test environment.
 Performed regression testing for the changes in Test environment.
 Responsible for carrying out Data Migration testing.
 Developed/Maintained the Requirements Traceability Matrix (RTM).
 Maintained Training Logs and Incident/ Test Case Assignment logs.
 Coordinated with Business and Technical folks in developing a rationale for unresolved Defects.
EDUCATION: Master’s IT Project Management Westcliff University, USA.
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Sudhir Panjwani

NovoBiotic Pharmaceuticals, MA Jul 2019 – Present

Client: West Ward Pharma, NJ Feb 2017 – Jun 2019

Client: Salix Pharmaceuticals, NC Oct 2014 – Jan 2017

EDUCATION: Master’s IT Project Management Westcliff University, USA.

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