You will get Enhancing Business Processes through Strategic Systems Analysis
Project details
My project stands out due to my extensive experience as a Senior Business Analyst and Validation Analyst in regulated Pharma & Healthcare industries. With over 9 years of expertise, I bring a deep understanding of regulatory requirements and validation processes, particularly in Risk-Based approach validation. My proficiency in drafting various documentation, providing CSV services, and implementing cloud-based applications adds immense value to my project. Additionally, my certifications in Azure Fundamentals and Packet Tracer showcase my commitment to staying updated with relevant technologies. Combined with my strong communication skills and ability to collaborate effectively with stakeholders, my project is poised for success in delivering robust solutions that meet regulatory standards and exceed client expectations.
Data Tool
Microsoft ExcelWhat's included
| Service Tiers |
Starter
$50
|
Standard
$250
|
Advanced
$1,000
|
|---|---|---|---|
| Delivery Time | 4 days | 8 days | 12 days |
Number of Revisions | 1 | 1 | 2 |
Source Code | - | - | - |
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AA
Amanda A.
Jul 30, 2025
Human Resource Work
Umair helped us evaluate candidates in a timely and helpful way. We're thankful for the help and would consider working together again.
About Umair
Product/Project Manager, Business Analyst Expert(Monday, Asana), 12+
Coral Springs, United States - 7:05 am local time
I'm Umair with 10plus years of working experience as a BSA. I'm an Experienced Project Manager with advanced knowledge of KNEAT, QMS, VEEVAVAULTSAFETY, QTEST, Tosca, Salesforce, AERS, CTMS, ERP, Trackwise, R&D Lab Systems, JIRA, ASANA, CLICKUP, TRELLO, Excel, Docs, PPT, G Suite, and other project management software to efficiently track progress, manage tasks, and facilitate seamless collaboration.
Expertise in project management methodologies such as Agile, Scrum, Kanban, and Waterfall keeping in view the requirements of clients and projects.
Have strong skills in planning, execution, and team leadership.
✅ Over 10 years of experience as a Senior Business Analyst and Validation Analyst in regulated Pharma & Healthcare industries.
✅ Proficient in utilizing Risk-Based approach to validate Category 3, 4 tools, and custom developed systems.
✅ Skilled in drafting User Requirements, Functional Requirements, Work Instructions, User Manuals, data mapping, and Training Manuals.
✅ Extensive experience in providing CSV services across various applications and infrastructure including LabWare LIMS, SharePoint 2013, Oracle AERS, CTMS, SAP ERP, and TrackWise 8.
✅ Proficient in creating Business Analyst documents such as Requirements, Use Cases, Storyboard discussion documents, and Workflow Use Cases/workflows.
✅ Expertise in developing validation deliverables like URS, FRS documents, Risk Assessments, Gap
✅ Analysis documents, OQ/PQ test scripts, Deviation/Incident Reports, Change Controls, and ✅Nonconformance Reports.
✅ Excellent knowledge of Cloud-based application implementation with expertise in AWS and SFDC.
✅ Proficient in utilizing Quality Center/ALM for managing tests and defects.
✅ Experienced in providing training to business users on Good Documentation and Test Execution Practices.
✅ Developed functionality Test Scripts based on approved system requirements.
✅ Proficient in testing methodologies, strategies, and Software Development Life Cycle (SDLC).
✅ Skilled in MS Office suite including MS Visio, MS Word, MS PowerPoint, and Excel Spreadsheets.
✅ Understanding of various life cycle methodologies such as Waterfall, Scaled Agile, and Agile.
Involved in Change Control and Change Management Process.
Steps for completing your project
After purchasing the project, send requirements so Umair can start the project.
Delivery time starts when Umair receives requirements from you.
Umair works on your project following the steps below.
Revisions may occur after the delivery date.
Initial Consultation
Meet with the client to discuss project objectives, scope, and expectations. This step establishes clear communication channels and builds rapport.
Requirement Gathering
Gather detailed requirements through interviews, workshops, and documentation analysis. This stage ensures a thorough understanding of the client's needs and constraints.