Pradeep Vemala — Associate Consultant

With a well-rounded professional career spanning over a decade, I bring a unique combination of domain versatility and technical leadership to the areas of Computer System Validation (CSV), Quality Assurance, and Software Testing. Over the past 4+ years, I have specialized in GxP-regulated Life Sciences environments, supporting pharmaceutical and medical device organizations in achieving regulatory compliance and delivering high-quality, audit-ready computerized systems. Prior to this, I led testing initiatives across the telecom, construction, and healthcare industries, providing a strong cross-functional foundation in test strategy, execution, and team leadership. In the Life Sciences domain, I operate at the intersection of quality and compliance—applying deep knowledge of FDA 21 CFR Part 11, EU Annex 11, EU GMP Annex 1, and GAMP 5 guidelines to deliver validated clinical, pharmacovigilance, R&D, and enterprise-level systems. My responsibilities span the full CSV lifecycle, including validation planning and execution, risk assessments, data integrity, and authoring of key documentation such as Validation Plans, IQ/OQ/UAT/PQ protocols, Traceability Matrices, and Summary Reports. I’ve also adapted to emerging regulatory expectations, including FDA’s Computer Software Assurance (CSA) approach to validation. With a background as a Testing Lead, I bring strong expertise in software development life cycle (SDLC) compliance, test strategy formulation, system integration testing, and defect management across both agile and traditional delivery models (Agile Scrum, Waterfall, V-Model, SAFe). My testing roots enable me to approach CSV with a quality-first mindset and an in-depth understanding of system behavior and validation needs. I am also experienced in building frameworks for Quality Management Systems (QMS)—including SOPs, work instructions, and templates—and conducting quality risk assessments, including GDPR, data integrity, and cloud compliance assessments. I actively practice deviation and CAPA management, ensuring sustainable compliance through effectiveness checks and continuous improvement initiatives. Proficient in tools like Microfocus ALM, Veeva Vault, ValGenesis, ServiceNow, DocuSign, JIRA, QDoccS, and Monday.com, I blend both technical and regulatory insight to drive successful project delivery and compliance. If you're looking for an experienced quality and validation professional with a rich history in testing, regulatory interpretation, and continuous delivery excellence—let’s connect.

Stackforce AI infers this person is a Quality Assurance and Validation Specialist in the Life Sciences sector.

Location: Mississauga, Ontario, Canada

Experience: 8 yrs 5 mos

Skills

Computerized System Validation (csv)
Quality Assurance

Career Highlights

Over a decade of experience in CSV and Quality Assurance.
Expertise in GxP-regulated Life Sciences environments.
Proficient in multiple testing methodologies and tools.

Work Experience

Billennium

Senior Validation Analyst (1 yr 8 mos)

Senior Validation Analyst (4 mos)

Cognizant

Senior Associate (Validation Lead) (2 yrs 6 mos)

PK

Quality Engineer II (Client: InEight) (2 yrs 10 mos)

InEight

Quality Engineer II (11 mos)

IBM

Test Automation Specialist (3 yrs)

Education

Bachelor's Degree at ADITYA ENGINEERING COLLEGE

Pradeep Vemala

Associate Consultant

Mississauga, Ontario, Canada8 yrs 5 mos experience

Key Highlights

Over a decade of experience in CSV and Quality Assurance.
Expertise in GxP-regulated Life Sciences environments.
Proficient in multiple testing methodologies and tools.

Stackforce AI infers this person is a Quality Assurance and Validation Specialist in the Life Sciences sector.

Contact

Skills

Core Skills

Computerized System Validation (csv)Quality Assurance

Other Skills

Agile & Waterfall MethodologiesAgile MethodologiesAgile TestingAndroid TestingComputer ScienceCorrective and Preventive Action (CAPA)Data AnalysisDefect TrackingDefect TriageEngineeringEnglishFunctional TestingGAMPGood Manufacturing Practice (GMP)Jira

About

Experience

8 yrs 5 mos

Total Experience

2 yrs 1 mo

Average Tenure

2 yrs

Current Experience

Billennium

2 roles

Senior Validation Analyst

Oct 2024 – Present · 1 yr 8 mos

Senior Validation Analyst

Jun 2024 – Oct 2024 · 4 mos

Cognizant

Senior Associate (Validation Lead)

Nov 2021 – May 2024 · 2 yrs 6 mos · Mississauga, Ontario, Canada

Create/update and execute validation testing documentation for GXP Products
Create, review and update of validation deliverables, including Test protocols, test cases/scripts
Ensure all validation testing meets system/product requirements as per the GxP standards
Develop strong product expertise and work with Product Managers/Business Analyst to ensure requirements/specifications are defined in a clear, testable format
Effectively work with cross functional teams
(Product Management, IT Operations Operations) to ensure the validated state of the system is maintained
Ensure requirements are adequately tested following a risk-based approach Identify and log issues found during validation execution
Skills: Verification and Validation (V&V) •
Computerized System Validation (CSV) • Quality
Assurance • Software Development Life Cycle (SDLC)
Test Planning • Microsoft Office • U.S. Title 21 CFR
Part 11 Regulation • GAMP

Verification and Validation (V&V)Computerized System Validation (CSV)Quality AssuranceSoftware Development Life Cycle (SDLC)Test PlanningMicrosoft Office+2

Pk

Quality Engineer II (Client: InEight)

Jan 2019 – Nov 2021 · 2 yrs 10 mos · Bengaluru, Karnataka, India · On-site

Client: InEight
Roles & Responsibilities:
 Easily define standardized questionnaires and checklists
 Use any mix of question types, including pass/fail, multiple choice, and more
 Make inspections foolproof with drill-down, follow-up questions tied to specific responses
 Understood the requirements through Functional study of the application.
 Participating in preparing Test Plans.
 Prepared Test Scenarios, Test Cases for functional, integration, and system testing.
 Prepared Test Data for the test cases and Smoke Tested the Environment to execute the test cases.
 Peer Reviewed the Test cases.
 Executing the Test Cases and tracking the defects till closure.
 Prepared and shared Summary Reports on a daily, Weekly basis with the Onsite leads and clients.
 Prepared Lesson Learnt documents from the previous project testing experience.
 Effectively participated in meetings with the Test Lead / Test Manager and the client.
 Conducted KTs, Review Meetings within the Team.
 Defect Tracking and Reporting in Microsoft VSTS.
 Direct interaction with client sprint after sprint demonstrating the Product that we developed as a team in that sprint.

Ineight

Quality Engineer II

Feb 2018 – Jan 2019 · 11 mos · Bengaluru, Karnataka, India · On-site

Had a great learning curve involving Mobile(Android & iOS) & Web application QA testing. Mobile testing where iOS device app testing was the primary focus. I had tested all iOS devices(iPAD, different iOS devices, and their compatibility testing. I had the privilege to showcase the product demonstrations with the Product Owner and all stakeholders every sprint.
> Provided estimates for user stories
> Analyzing the user stories.
> Created Scenario break down for all the User Stories
> Designed Test cases for Inspect Application within Microsoft VSTS.
> Created test cases covering all test cases like Negative test cases, UI test cases, localization test cases
Reviewing the test cases written by peers.
> Finding bugs in the Application and raising the defects in VSTS
> Given KT to other team members about the Application.
> Pseudo and Localization Validation
> Executed Regression Test Cases, Defect tracking, and Closure Activities, Demonstrated the application
based on user stories to the product owner
> Handling a team of three to Inspect mobile application
> Attending daily stand-up meetings for status updates
> Active participation in Retrospect meetings
> Moving the stories to RFA state by providing final sign off

Ibm

Test Automation Specialist

Feb 2015 – Feb 2018 · 3 yrs · Bengaluru Area, India

Got an opportunity to Learn the fundamentals of Telecom Industry and it's operations with the Clients. Acquired basic knowledge on the WHY_HOW areas in Testing Domain with Etihad Group of companies based out of KSA(Kingdom of Saudi Arabia)