Shreya B. - QMS Solution Architect

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Neu-Isenburg, Germany

Experience

Apr 2024 - Present

1 year 5 months

QMS Solution Architect

SLK Software

Participate in quality workshops for requirements gathering and fit/gap analysis
Demonstrated different QMS modules/processes with focus on customer requirements
Design and implementation of cloud based quality system reducing manual efforts for the client
Collaboration with cross functional teams to define and document system requirements
Understanding the existing business process flow and suggesting improvements over moving to new quality systems
Managed the implementation of a data migration strategy from legacy system to cloud
Providing solution walkthrough to the business users
Involved in integration of quality system with different third party systems
Preparing weekly status report and presenting the same to business users and project stakeholders

Sep 2023 - Mar 2024

7 months

QMS Lead

Cognizant Technology Solutions

Involved in requirements gathering and fit or gap analysis for different business units
Collaborated with cross functional teams to analyze potential system solutions based on evolving client requirements
Preparation of technical and functional specification documents and documenting business processes in the workflow diagrams
Providing solution walkthrough to the business users
Migrating data from existing QMS systems to Veeva Vault
Regular engagement with key customer stakeholders to proactively drive the project success
Estimate and manage the development of new functionalities and enhancements to the existing ones
UAT assistance

Apr 2023 - Aug 2023

5 months

Test & Validation Lead

Cognizant Technology Solutions

Involved in end to end validation activities for critical manufacturing project
Creation and execution of validation testing plan
Develop and execute tests for new products/features and continuous improvement initiatives
Analyze data, summarize and document test results
Involved in the transition of non risk based testing to risk based testing approach
Preparation and review of validation plan, test script inventory, execution results inventory and validation report in Polarion
Involved in maintenance support activities like preparing maintenance plan and report
Involved in risk assessment and mitigation of risks
Preparation of weekly status report and presenting the same to business users and stakeholders

May 2022 - Mar 2023

11 months

Project Lead

Cognizant Technology Solutions

Plan and lead project with business process owners to translate the IT strategy into business specifications and sign off the requirements with applicable stakeholders
Facilitate discussions with business owners about project deliverables and scope, develop project plan, hiring of resources, manage budgets and track project deliverables
Involved in risk assessment and mitigation of risks
Implementing ETQ change requests and automated business processes (workflow, approval process, process builder, validation rules) for complaints handling and supplier modules
Providing implementation/solution walkthrough to the business users
Master data management using Oracle Apps transferring approved material, supplier and ETQ codes details into ETQ from MDM
Preparation of weekly status report and presenting the same to business users and stakeholders
Preparation of technical documents related to ETQ & MDM applications
Leading the end-to-end transition activity between Cognizant and 3rd party vendor
Involved in resource planning, effort estimation, preparing the SOW, billing and revenue related activities for the team, managing timesheets and ensuring the team is compliant

Jun 2021 - Apr 2022

11 months

Team Lead

Cognizant Technology Solutions

Worked in deviation management, audits & inspections, supplier quality and complaints & issue escalations modules
Requirement gathering, project planning & estimation
Creation and modification of user accounts and roles, configuring changes using Veeva Admin
Creation of workflows, page layouts, email templates and validation rules to implement the business logic
Created custom reports for standard objects as well as custom objects to provide detailed overview of data
Preparation and execution of IQ
Writing system test scripts and executing the same
Identifying & tracking of defects

Jun 2020 - May 2021

1 year

Test Lead

Cognizant Technology Solutions

Participate in requirement gathering, raise clarifications with customer and track them till closure to eliminate any ambiguity on the scope of work assigned
Define and implement the testing scope, strategy and test stage plans for the project according to the best QA practices
Responsible for project planning, management, coordination and reporting for all test related activities across all the testing phases (system, integration, end-to-end & acceptance)
Preparation & review of system test cases for complaint, CAPA and deviation modules
Ensure the appropriate test environments are in place, prepare and document test data for complex system testing
Optimizing test cases for validation
Release & risk analysis, preparation and maintenance of test cycles in JIRA
Execution of the test cases and identifying bugs
Preparation of summary report and presenting the same to business users
Assisting the users during UAT
RFC effort estimation

Dec 2019 - May 2020

6 months

Tester

Cognizant Technology Solutions

Creation of user accounts, roles and groups using TrackWise Web Admin
Preparation & review of system test cases
Execution of the test cases
Assisting users during UAT
Preparation of training manuals for end users
Providing a walkthrough to the end users
One-to-one interaction with business users

Sep 2015 - Dec 2019

4 years 4 months

Application Developer Lead

Tata Consultancy Services Ltd

Application support and maintenance
Apache Tomcat server monitoring and maintenance
Design workflow based form using ETQ tool working in MDD nonconformance, CAPA, audit, supplier and complaints handling modules
Customize the forms using Python script as per client need
Master data management
Worked on business on-boarding activity for different applications and business units
Preparation and execution of IQ
Involved in interface testing
Implementing change requests
Resolving incidents and tasks using Service Now
Writing system test scripts and executing the same
Assistance to users during UAT
Development of filters, calculations and creation of reports using Qlik Sense reporting tool
Mentored trainees and associates and helped them gain project knowledge in ETQ Reliance application

May 2012 - Aug 2015

3 years 4 months

Tester

Tech Mahindra

Preparation & review of test cases
Execution of the test cases
Conducting various domain-related sessions for the complete team
Discussion with various components for analyzing the root cause of IVVT defects
One-to-one interaction with the customer

Summary

12+ years of IT experience in the areas of Quality Management, Quality Assurance and Testing/Validation for GMP and GCP regulated environments.
Sound knowledge in ETQ, Veeva QMS, TrackWise, UNIX, SQL, Service Now, SAP QM, Java, HP QC/ HP ALM, JIRA & Confluence.
Certified Scrum Master.
Veeva Vault White Belt certified.
AWS Cloud Practitioner certified.
Knowledge of core QA systems like CAPA, Deviations, Complaints Handling, Audit and Change Management.
Hands on experience in Validation, Unit testing, Functional, Interface testing, UAT and Integration testing.
Performed Black Box, White Box, System Testing, GUI and Regression Testing.
Experienced in Project Management, product management and Stakeholder Management across cross-functional teams.
Well versed in Reporting using Qlik Sense and MS Excel.
Knowledge of FDA regulations, validation and compliance requirements related to quality assurance.
Strong understanding of business and quality processes of Pharmaceuticals and Medical Devices.
Extensive knowledge of Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC).
Excellent knowledge and hands on experience in handling incidents, SLA and problem management scenarios.
Proven ability to troubleshoot and identify the root cause of issues (RCA).
Excellent problem solving skills with a strong technical background and good interpersonal skills, accustomed to working in a team and capable of working under pressure.