Quality Assurance Engineer

Mausami Pradhan

QUALITY ASSURANCE ENGINEER /

VALIDATION ENGINEER

A highly competent and results-oriented Quality Assurance Engineer having 5 years of experience in manual and automated testing in the healthcare industry in a regulated environment. Intensive experience in conducting internal and external non-clinical audits on safety and biocompatibility studies to ensure conformance to 21 CFR Part 11, GxP, GAMP, and SOPs.

PROFESSIONAL SUMMARY

A highly motivated, dedicated self-starter test engineer with proficient experience in Software Quality Assurance testing.

Strong experience in performing manual and automated testing. This includes understanding requirements, creating test plans, writing test cases, creating execution plans, bug creation, tracking, test case automation, monitoring, and reporting.

Quality Compliance Auditing Specialist with strong knowledge and understanding of 21 CFR Part 11 which includes Electronic Records and Electronic Signatures along with its components with GxP guidelines.

Expertise in conducting assessments for GxP (GMP, GLP, GCP, GDP) suites, Risk Assessment (High, medium, low), Security Assessment, and documentation as per GAMP 5 (Good Automated Manufacturing Practice) guidelines.

Having good Knowledge and experience in Computer System Validation (CSV), System Requirement Specification, Documentation of Validation activities, Validation Plan, Validation Procedures, and Validation Report.

Experience in the generation and execution of Validation master plan (VMP), Requirement Specification (URS), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and validation summary reports making sure to cover all gaps and deviations in the report

Experience in Automating tests using open-source tools such as Selenium (Selenium IDE, Selenium RC, Selenium Web Driver, and Selenium Grid), Cucumber, and Jira.

Experience performing automated testing in both Web and Mobile applications

Strong knowledge and background in Software Development Life Cycle (SDLC), good understanding of waterfall and agile methodologies.

Experience in creating and reviewing User Requirement Specification (URS), Functional requirement Specification (FRS) documents, Writing Test Scripts, Performing Risk Analysis, and creating Test Plans

Co-ordinated with system owner and business analyst to set up Pre-validation and validation environment to execute the scripts.

Good experience in Unit, Integration, Functional, Validation, System, and Regression Testing.

Conduct GLP in-life phase and final report audits including complex assessments, to ensure conformance with applicable regulations, standards, and Edwards' policies and procedures.

Location: Pittsburgh, PA

Mobile: +1-301-***-****

Email:

*******.*******.*@*****.***

LinkedIn:

www.linkedin.com/in/mausami291

Top Skills

Automation Testing

Manual Testing

GxP, GAMP and cGMP

Installation Qualification

(IQ)

Operational Qualification

(OQ)

Performance

Qualification (PQ)

Corrective & Preventive

Actions (CAPA)

Selenium

Cucumber, TestNG,

Maven, Eclipse

SQL

JIRA

Confluence

Microsoft Office Tools

Soft Skills

Teamwork

Problem-Solving

Creative

Management & Planning

Communication

Certifications

Quality-Assurance

Manual & Automated

Testing- 12 weeks -2018

Selenium

SQL & Data Analysis

Computer Validation &

Documentation

SKILLS

Validation Manual testing, Automated testing, 21 CFR Part11, Validation Protocol

(IQ,PQ,OQ), SOPs, GAP Analysis, RTM, Risk Assessment, Incidents, Summary Reports.

SDLC Waterfall and Agile Model, V-Model, GAMP-5

Tools SQL, MS-Word, MS-Excel, MS-PowerPoint, PDF generators Environment 21 CFR Part11, SDLC

Testing tools HP (Quality Center)ALM, JIRA, TrueVolt, Trackwise, Veeva Vault Artifacts Test Plan, Test Case, Test Data, RTM, Test Summary Report, Bug report, QA Audits, Validation Summary Report,CAPA, RTM(Requirement Traceability Matrix

QA Automation Selenium, Cucumber, TestNG, Python

WORK HISTORY

Key Roles and Responsibilities:

• Lead the team in conduc\ng Part 11 assessments, par\cularly focusing on components related to Electronic Records (ER), Electronic Signatures (ES), and Audit Trails in accordance with 21 CFR Part 11 regula\ons.

• Dra]ed & updated technical specifica\ons for new business processes and generated valida\on documenta\on.

• Conducted end-to-end pla`orm qualifica\on and execu\on for various tools including Dremio, Privacera, Tableau, Cloudera, Databricks, Acryl Datahub, Dataiku, Metabio, Change Data Capture- Bryteflow, and Collibra OWLDQ.

• Developed and implemented Technical EvaluaWons (TE), IniWal Technical Assessments (ITA), PlaXorm Design & ConfiguraWon SpecificaWons (PDCS), SOPs compliant with GAMP regula\on & FDA standards, Work InstrucWons, Audit Trail Review WIs (ATR WI), Traceability Matrices, Summary reports, and validaWon templates.

• Analyzed User and Func\onal requirements to formulate Test Plans, Test Cases, and Test Scripts using HP ALM, and executed them accordingly.

• Collaborated with Technical Subject Macer Experts (SMEs) to ensure applica\on configura\ons aligned with Business Requirement Documents (BRDs) and Test Scripts, conduc\ng dry runs and providing feedback to the CSV Program manager.

• Create Change Controls and engage with Quality & Business stakeholders confirming change implementa\on, ensuring closure of Change Controls in Valida\on Environment.

• Executed IQ and OQ Test Scripts of LIMS applicaWon, documen\ng results and compiling Test Script Summary reports, ensuring prompt resolu\on of test defects.

• Func\oned as Test Coordinator during script execu\on, ensuring all protocol devia\ons or devia\ons from acceptance criteria were adequately addressed by the QA team.

Education

Lalit Narayan Mithila

University - 2019

ECE – California College of

ECE (CerBfied with 24

Units)

GED – Fremont Adult

EducaBon

CBSE – Deepika English

Medium School

Hobbies

I enjoy traveling to

explore new culture and

desBnaBons.

I am passionate about

photography and

capturing moments

I enjoy hiking and going

on trails.

Regeneron

- Validation Lead

- Remote

- Contract Via SecureKloud

- June 2023 – Present

System

- GxP Implementation of Data

Platform Technologies

System Description

- The system aims to integrate

GxP into data platform

technology, ensuring reliability,

compliance, and efficient Data

Management in regulated

industries.

Key Roles and Responsibilities:

• Performed Quality Assurance responsibilities by reviewing validation deliverables for various projects for compliance with SDLC, CSV, 21 CFR Part 11 requirements, and GxP regulations.

• Recorded investigation progress, CAPAs, and effectiveness checks in TrackWise.

• Facilitated interdepartmental software project delivery for the IT Compliance team and fostered the design and update of Group Policy for GxP compliance data integrity project.

• Designed the High-Level Risk Assessment for the computerized system concerning regulatory, legal, and information security topics from GxP, SOX, and HIPAA requirements.

• Understood and complied with regulations of 21 CFR Part 11, Annex 11, and all company processes as outlined in Standard Operating Procedures (SOPs)

• Extensively worked with various software issues tracking & test defects tools like JIRA, HP ALM, and Rally.

• Created and maintained automation acceptance test suite using Selenium, Ruby, and Cucumber framework.

• Baseline the test plan, test criteria, and project schedule by walkthroughs and report the defects using HP ALM.

• Reviewed & planned internal IQ, OQ, and PQ documentation against the requirements and assisted with validation execution and approval of documentation.

• Validation for SAP Upgrade to ECC, which included the creation of validation deliverables including a Compliance Plan, Compliance Report, Data Conversion, and Migration Protocols and reports.

Key Roles and Responsibilities:

• Developed 21 CFR Part 11 Risk Assessment, Security Assessment, and document as per GAMP 5 guidelines for the project.

• Analyzed Test Script to check if it has covered the GDP functionalities, which need to comply with 21 CFR Part 11 rules set by FDA.

• Automate test cases using Cucumber and Ruby, Selenium/Java, and build a Framework for cloud-based applications from scratch

• Excellent experience in the Validation of Computer Applications such as LIMS, Data Integrity, and Pharmaceuticals/ Biologics.

• Familiar with Regression testing, Data Driven testing, UAT (User Acceptance Testing)

• Experience in SQL queries (inner/outer join…) to validate data. Use SQL viewer to execute SQL queries.

• Interact with the application development teams for the design, testing, and deployment of new features.

• Wrote & updated current operating procedures and developed new standard operating systems (SOPs) to ensure compliance with the company’s processes, policies, and procedures.

• Opening of investigations and addressing deviations on protocol by Corrective and Preventive actions Plan (CAPA).

Roxane Laboratories, Inc.

- QA Validation Engineer

- Columbus, Ohio / Remote

- Contract Via SecureKloud

- Sept 2021 – June 2023

System

- Quality Management System

(QMS)

System Description

- This system involves

implementation of validation

process in Quality Management

System upgrade project following

21 CFR Part 11 requirements and

GxP regulations.

Three Rivers

Pharmaceuticals, LLC

- Validation Engineer

- Pittsburgh, PA / Hybrid

- Contract Via SecureKloud

- June 2019 – Sept 2021

System

- Laboratory Information

Management System (LIMS)

- Quality Management System

(QMS)

System Description

- The system helps to process

information in medical research

to improve the efficiency of the

department services and

laboratory operations by reducing

manual tasks and procedures.

Key Roles and Responsibilities:

• Responsible for testing and validating existing and new features within the Healthcare domain. Make sure all new product offering information is accessible by the end customer and they can reach out to sales representatives by submitting contact details.

• Understanding of healthcare regulation with the ability to use testing within their frameworks. Using Page Object Model and Page Factory for developing the POM framework.

• Develop Selenium scripts to locate, Verify, Select, and perform various operations on Web elements in the Healthcare domain.

• Working in handling Multiple windows, alerts, and cookies using the switch and navigate commands, Down Menus, Mouse Actions, Keyboard Actions, Frames, and all types of Pop-Ups using Selenium.

• Use Selenium WebDriver to handle the web tables and links on the web page.

• Perform Database testing by writing SQL queries to fetch the correct data from the database.

• Responsible for setting up Selenium Grid for Cross-browser and Cross-platform testing.

• Perform BDD (Behavior Driven Development) using Cucumber Features, Cucumber hooks, Scenarios, and Step Definitions in Gherkin format.

• Perform Parallel Testing and cross-browser testing on different browsers like Internet Explorer, Chrome, Safari, and Firefox where multiple tests were run at the same time using TestNG.

• Managing individual sprint user stories and tasks using JIRA as an Agile Management tool and Bug tracking tool.

• Using FireBug, and FirePath to debug, edit and locate the objects based on ID, Name, XPath, CssSelector, Link, Partial Link, Attributes, and Tags

• Involved in Web services testing using SOAPUI Tool by using the SOAP and Restful Web services for Validating request and response XML.

• Added assertions to validate the XML in Web services using the SOAPUI service.

• Performing Continuous integration using Jenkins and used to trigger the jobs at intervals of time.

SecureKloud

- Automation Test Intern

- Remote

- Sept 2018 – June 2019

Project

- Health Care Triangle

Description

- It provides a platform for the

health care and life science

industry which gives 360 degree

services and industry transforming

solutions. It is a cloud based digital

platform to Manage health

records, deliver personalized

patient engagement, automate

document workflows, implement

community connect programs, and

optimize care delivery processes. It

empowers all life science

organizations to propel

personalized medication,

accelerate data collaboration,

design better clinical trials, speed

up drug discovery and time to

market.

Contact this candidate