Summary
Overview
Work History
Education
Skills
Personal Information
Professional Development
Timeline
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Noman Khalid

Deerfield Beach,FL

Summary

Results-driven Business Analyst with 10 years of experience in the Life Sciences industry, specializing in GxP systems and the complete Software Development Life Cycle (SDLC). Proven expertise in documenting business and system processes, gathering user requirements, and delivering high-quality solutions in compliance with FDA and MHRA regulations. Adept at fostering relationships with stakeholders, managing end-to-end implementation projects, and leading initiatives through Agile methodologies. Highly skilled in developing User Stories, Quality Assurance (QA) deliverables, and standard operating procedures (SOPs) while ensuring effective communication across business and technical teams.

Quality-focused professional with robust background in validation and compliance within regulated industries. Expertise in executing validation protocols and ensuring alignment with industry standards, fostering operational excellence. Known for collaborative spirit and adaptability, consistently achieving results through teamwork and precision.

Professional validation analyst equipped for excellence in ensuring compliance and accuracy in processes. Skilled in quality assurance, data analysis, and risk assessment. Strong focus on team collaboration and achieving results, with flexible approach to changing needs. Reliable and adept at problem-solving, with keen eye for detail and dedication to maintaining high standards.

Overview

12
12
years of professional experience

Work History

Business / Validation Analyst

Baxter
10.2022 - 11.2024
  • Collaborated with stakeholders to document business processes, user stories, and system requirements for LabWare LIMS workflows and reports
  • Led requirements gathering and clarifications with technical teams using Agile techniques
  • Authored test logs and maintained test artifacts in HP ALM; tracked defects and produced comprehensive deliverables including Change Control, URS, and Risk Assessments
  • Supported end-to-end testing and coordinated efforts with implementation partners to ensure successful project go-lives
  • Managed incident resolution and communicated status updates to management and stakeholders
  • Projects: LabWare LIMS, CTMS, LMS, CIMS, JIRA

Business Analyst

Astellas Pharma
04.2020 - 09.2022
  • Led technical analysis and testing for Complaints Management and Supplier Audits, producing URS/FRS and FDA Part 11 assessments
  • Utilized Agile methodologies for managing Product and Sprint Backlogs in JIRA; validated SAP ECC 6.0 implementations
  • Developed OQ/PQ/UAT protocols and test cases while ensuring proper documentation of system issues and resolutions
  • Engaged with internal and external stakeholders to analyze business needs and facilitate solution delivery
  • Projects: Veeva Vault, JD Edwards, Medidata RAVE, CIMS, JIRA

Business Analyst

Cambrex Corporation
01.2018 - 03.2020
  • Analyzed requirements for compliance with 21 CFR Part 11 and GMP/GLP regulations; developed qualification plans and executed OQ/PQ/UAT testing
  • Trained users on UAT testing processes and performed risk analysis to maintain traceability matrices
  • Managed defect resolution and documented test evidence for compliance purposes
  • Projects: LabWare LIMS, MES System, Serialization Software, CIMS

Business Analyst / Validation Analyst

Covance
02.2013 - 12.2017
  • Developed and executed test strategies and protocols, guiding teams in OQ protocol development and regulatory assessments
  • Reviewed and issued documents using Documentum; maintained traceability matrices in HP QC
  • Communicated effectively with both business and IT teams to resolve issues and manage project risks
  • Projects: Clinical Trial Management System (CTMS), MES System – Werum PAS-X, SharePoint EDMS

Education

Bachelor’s - Commerce

University of Punjab
01.2011

Skills

  • HP QC/ALM
  • Micro Focus ALM
  • QTest
  • JIRA
  • MS Office Suite
  • MS Visio
  • MS Project
  • Azure DevOps
  • Waterfall
  • Agile
  • 21 CFR Part 210-211
  • Annex 11
  • GAMP 5
  • 803
  • 820
  • UAT/Test Plans
  • Compliance Risk Profiles
  • RTM
  • URS
  • FRS
  • OQ
  • PQ/UAT Protocols
  • SOPs
  • System Problem Reports
  • Process validation
  • Documentation review
  • Test method validation
  • Change control
  • Validation protocols
  • Computer system validation
  • Software validation
  • Problem-solving
  • Teamwork and collaboration
  • Time management
  • Attention to detail
  • Multitasking
  • Manual testing
  • Effective communication
  • Active listening
  • Functional testing
  • Bug tracking and resolution
  • Analytical thinking
  • Workload management
  • Training and onboarding

Personal Information

Visa Status: GC

Professional Development

Project Management Professional (PMP), 02/01/25

Timeline

Business / Validation Analyst

Baxter
10.2022 - 11.2024

Business Analyst

Astellas Pharma
04.2020 - 09.2022

Business Analyst

Cambrex Corporation
01.2018 - 03.2020

Business Analyst / Validation Analyst

Covance
02.2013 - 12.2017

Bachelor’s - Commerce

University of Punjab
Noman Khalid