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Abdul Khan

@abdulkhan5

Message

I validate GxP systems and lead FDA-compliant software quality and release activities.

United States

Message

What I'm looking for

I'm looking to contribute software quality, computer system validation, and regulatory compliance expertise to teams delivering reliable GxP-regulated systems. I value cross-functional collaboration, risk-based validation, data integrity, and continuous process improvement.

I'm currently supporting Abbott Labs as a Software Quality Analyst, guiding SDLC, validation, and compliance activities for GxP, SOX, and GDPR-relevant systems. I review requirements and design documentation, assess functional risk, and help approve releases through certification summary reporting.

Across Abbott, Cardinal Health, Pfizer, SPL, Taro Pharmaceuticals, and Sumitomo, I've validated regulated systems including electronic document management, adverse event reporting, LIMS, MRP II, and healthcare information systems. I've authored and reviewed URS, functional specifications, validation plans, IQ/OQ/PQ protocols, traceability matrices, test scripts, and validation summary reports.

I bring hands-on experience with FDA 21 CFR Part 11, GMP, GCP, GLP, data integrity, change control, CAPA, audit support, risk assessment, and backend data validation using SQL. I also support cross-functional teams with testing, defect resolution, compliance guidance, and process improvement.

Experience

Work history, roles, and key accomplishments

Current

Software Quality Analyst

Current

Abbott Labs

Jan 2023 - Present (3 years 8 months)

Provided SDLC guidance and support to delivery teams, reviewed user requirements and design documentation, and designed validation strategies for GxP and SOX/GDPR systems. Executed functional risk assessments and approved testing scripts.

SDLC GxP SOX GDPR Validation Strategy Functional Risk Assessment Test Script Approval Change Management

Software Quality Assurance Consultant

Abbott Labs

Oct 2021 - Dec 2022 (1 year 2 months)

Provided compliance review and approval of deliverables, supported data quality and integrity initiatives, and collaborated with development teams to ensure compliance and business needs.

Compliance Review Data Quality Data Integrity Process Improvement Audit Support

Validation Analyst

SPL

Jun 2020 - Sep 2021 (1 year 3 months)

Validated systems in accordance with FDA 21 CFR Part 11, authored IQ/OQ/PQ protocols, and ensured GMP compliance. Reviewed design documents and functional specifications, and executed test cases.

21 CFR Part 11 GMP IQ+Test Authoring Traceability Matrix Change Control

Sr. Computer Systems Validation Consultant

Cardinal Health

Jan 2019 - May 2020 (1 year 4 months)

Reviewed and approved validation deliverables for GxP regulated systems, provided CSV guidance, and participated in audits. Built relationships with stakeholders and monitored compliance.

CSV GxP Validation Documentation Audit Support Risk Management Stakeholder Management

Validation Analyst/QA

Pfizer Inc

Nov 2017 - Dec 2018 (1 year 1 month)

Validated users and interfaces for pharmaceutical environments, wrote test scripts for SAP and non-SAP systems, and developed IQ/OQ/PQ protocols. Conducted dry runs and supported change control.

Validation Test Scripts SAP IQ+UAT Traceability Matrix Change Control

QA Analyst

Sumitomo Incorporated

Feb 2016 - Oct 2017 (1 year 8 months)

Analyzed system design specifications and developed test plans, cases, and scripts. Performed manual regression testing and reported defects to development teams.

Test Planning Test Cases Test Scripts Regression Testing Defect Tracking Quality Centers SQL

QA/Validation Analyst

Taro Pharmaceuticals

Jan 2015 - Jan 2016 (1 year)

Performed IT system validation of LIMS for 21 CFR Part 11 compliance, developed functional requirements, and executed IQ/OQ protocols. Authored validation documents and traceability matrices.

LIMS 21 CFR Part 11 IQ+UAT Traceability Matrix Validation Documentation