Swachitha Sirasawada

Software Validation Analyst / BSA

857-***-**** ad2h1v@r.postjobfree.com Monroe, NJ

PROFESSIONAL SUMMARY

Over 7 years of experience in Health care medical devices Pharmaceutical and Finance industries as a Business System Analyst and Validation Analyst specializing in Computer systems, Business Analysis, Testing, Audits and Trainings.

Strong knowledge about Pharmaceutical/Medical device regulations like FDA: 21 CFR Part 210, 21 CFR Part 211 and 21 CFR Part 820 and involved in implementation of CFR Part 11 rules (Electronic Records, Electronic Signatures, Audit Trails, and Security events).

Extensive validating experience in FDA regulated environment with good understanding of cGxP (GMP, GDP, GCP and GLP).

Experienced in Software Development Life Cycle (SDLC) and Software Testing Life Cycle (STLC) and software development methodologies such as Agile Scrum, V Model and Waterfall.

Experience in supporting new system implementation, upgrade, enhancements, and rollout projects.

Strong experience in developing end-to-end validation deliverables including developing Validation Plan, Requirements Specifications, Design/Configuration Specifications, Traceability Matrix, Test plan, Test Reports, Deviations and Validation Summary Reports for multiple projects.

Worked as an interface between technical and business environments for gathering and conveying User Requirements Specifications (URS), Functional Requirement Specifications (FRS), Functional/Business Process Risk Assessment and Design Specifications (DS)

Performed risk assessment using the FMEA methodologies and Gap Analysis.

Developed remediation Plans, and designed Requirement Traceability Matrix (RTM).

Extensive experience in using HP ALM for requirement management, test script creation, pre-execution approval, execution, post-execution approval and defect management.

Experience in validating and approving the Change Control Forms for QA and ensured the overall risks of all the transports met the Business Criticality.

Hands on experience in writing documentation and execution of Qualification Protocols including Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ).

Strong experience in Positive testing, Negative testing, Integration Testing, Functional Testing, System Testing, Regression Testing, Data Migration testing and User Acceptance Testing (UAT), Database testing, Security and Usability testing.

Experience in developing manual and automated Test scripts and test cases based on the client provided BRD, FRS and SRS.

Experience in project management tools: JIRA, Pivotal, HP ALM

Detail oriented, good communication skills and ability to work independently or as a team player.

TECHNICAL SKILLS

Computer System Validation: 21 CFR Part 11, 210,211,820, GAMP, cGxP (cGMP, cGDP, cGLP), Validation Plan, Requirements Specifications, Design/Configuration Specifications, Test Plan, IQ, OQ, PQ, RTM, SOPs, FMEA, RTM, SOP, CR, DPP, Summary Reports, Audit Trails, Share Point

Testing Tools: HP ALM, SOAP UI, Postman, SOA Test

Business Tools: Pivotal, JIRA, MS Office (Word, Excel, Active directory, Power Point, Access, Visio), Documentum, SQL, Miro, Figma, Migration tools.

Databases: Oracle, PL/SQL, MS SQL Server.

Project Methodologies: SDLC, Agile/Scrum, Waterfall.

Operating Systems: Windows, Unix, Mac OS

Bug Tracking Tools: HP ALM, Pivotal, Quality Center, Bugzilla, and JIRA.

PROFESSIONAL EXPERIENCE

Abbott, IL March 2021 – Sep 2023

Validation Analyst / BSA

Responsibilities:

Worked for the NAVICA suite of products which includes NAVICA Consumer Mobile, NAVICA Consumer Web, NAVICA Administrator, NAVICA Verifier, NAVICA Connect, NAVICA At-Home Testing and NAVICA Reporting.

Worked for consumer facing ecommerce website and customer information platform provided as a single digital solution (web application) to enable the ARDx Wellness Program (KNOWme). The platform will allow customers to purchase at-home self-tests, follow instructions to correctly perform at-home self-tests and send the resultant samples to a predetermined lab, as well as track and manage test results.

KNOWme application hosted on Microsoft Azure and will utilize Adobe Experience Manager (AEM) for content management (AEM) and Magento for ecommerce services. It includes integrations with a third-party Ordering Provider, Abbott StarLIMS labs system, an Abbott ARDx ERP, third party fulfillment provider, payment processor, Payment Gateway, ARDx customer service solution(s), KNOWme CSR Portal, Marketing service provider, and Databricks. AEM (Adobe Experience Manager) used to support design content for KNOWme Front end. CSR portal is used as a tool to provide customer support to end users. Data lakes/Data Bricks is a business intelligence platform for internal data metrics analysis. Data lake application receives data from the KNOWme & CSR portal which include system availability data, marketing data, usability data, and transactional data.

Created and executed Requirements, Defects and Operational Qualifications, test protocols within ALM (Application Lifecycle Management).

Reviewed and approved key project deliverables for quality systems (software quality assurance (SQA) activities) as defined in the Project/Validation plan.

Worked on cGxP (GMP, GDP, GCP and GLP) regulations when defining the functional requirements.

Ensured that the system is compliant with applicable Abbott policies, processes, procedures, and global quality regulations.

Escalated regulatory concerns/decisions to appropriate project team members and/or regulatory SMEs.

Review, analyze, and evaluate business systems and user needs.

Preparing, review and updating Computerized System Validation documents: User Requirement Specification (URS) & Functional Requirement Specification (FRS) that satisfied business requirements.

Review and assess the user stories/requirements based on their criticality (GxP Critial, Critical(pii), non-Regulatory).

Documented and reviewed change request documents. Prepared and reviewed FRS Impact assessment.

Created and reviewed Computerized System Validation documents: Requirements Traceability Matrix to define the relationship between Functional Requirement Specification, Design Document, Test Scripts (OQ).

Document requirements define scope and objectives and formulate systems to parallel overall business strategies.

Worked on 21 CRF part 11 for system to assure that the first component of an electronic signature (e.g., user ID) cannot be reassigned to, reused by, or shared with another person.

Accountable for analyzing product impacts and includes responsibilities around documenting and delivering on Abbott’s compliance documentation, policies, and procedures for Digital Products.

Authoring, Executing and Review test scripts to assess functionality, reliability, performance, and quality of the service or product.

Developed, reviewed and executed the system related Operation Qualifications (OQ).

Recommend, implement, monitor preventative and corrective actions to ensure that quality assurance standards are achieved.

Documented and reviewed Computerized System Validation documents: Functional / Business Process Risk Assessment for Identify failures, estimate risks, prioritize actions, Evaluate design/control plan.

Defined the scope for compliance, and for any other risk that is included for Business, Health & Safety reasons.

FMEA (Failure Mode and Effect Analysis) Identify Known and/or Foreseeable Hazards, Failure Cause and Means of Detection, Severity Levels, Probability of Occurrence Levels, Probability of Detection Levels, Determine the Risk Criticality, Determine the Risk Mitigation Strategy, Risk Management and Follow-up, Evaluate the Efficiency of the Risk Mitigation.

Worked on Risk Management Report (RMR) following the Quality Risk Management guidance applicable for computer applications supported by BTS IT.

The purpose of Risk Management Report (RMR) is to summarize the results of functional risk management activities, including assessments, ratings determined in the Requirements Specification (RS), and to define commensurate controls / mitigations, determined for the Digital Wellness-Colibri.

The RMR is intended to mitigate risks in computerized applications that have the greatest potential to compromise patient safety, product quality and / or data integrity.

Bank of America, NJ Jun 2019 – Aug 2020

QA Analyst

Responsibilities:

Worked in the Agile/scrum development environment with active requirements and features. Good experience in using JIRA tools.

Analyze business requirements, acceptance criteria mentioned in user stories.

Created the test plan and strategy document that defines the test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required to conduct the effort.

Performed functional testing of SOAP and RESTful Web Services by using SOATest and POSTMAN Tools

Performed database testing, data accuracy, data validation and data integrity testing by querying the database using SQL queries to check the data table on server.

Performed parallel and cross browser testing for all the test scripts.

Performed Accessibility testing using JAWS, IPROWE tools as per the WACAG 2.1guidelines.

Performed Integration Testing, Functional Testing and Regression testing.

Performed User Acceptance Testing in the final phase of software development process to check the functionality of the ETCDT portal.

Used JIRA tool for defect management – Raise the defect, tracking, conduct defect meetings to update the status of all the defects on periodical basis, publish a consolidated list on weekly basis.

Performed System, Integration and Regression Testing.

Syneos Health, NJ Aug 2015 –Mar 2019

Validation Analyst

Responsibilities:

Created, reviewed, and approved User Requirement Specification (URS) & Functional Requirement Specification (FRS) that satisfied user requirements.

Complied in strict accordance with FDA and GCP regulations for all aspects of computer systems validation cycle.

Validated computer systems in accordance with FDA published cGMP, cGLP and cGCP guidelines.

Prepared, reviewed, and approved Validation Plan, Test Plan, Test Cases, Test Summary Report and Validation Summary Report.

Execute Test Cases and report the Test Results to the project management teams.

Developed, reviewed and executed Computerized System Validation documents: system related Installation Qualifications (IQ), Operation Qualifications (OQ) and Performance Qualification (PQ).

Prepared or Revised Requirements CSV document Traceability Matrix

Supported testing team in conduct root cause and impact analysis to raise the deviation/defect and define corrective and preventive actions

Worked on 21 CRF part 11 for system providing the access to complete records and documents in human readable form.

Worked on 21 CRF part 11 for system providing the provide (e.g. reports) indication if any data has been changed (e.g. corrected) since the original entry.

Worked on 21 CRF part 11 for system capable of detecting invalid or altered records.

Worked on 21 CRF part 11 for system prohibit access by unauthorized users.

Worked on 21 CRF part 11 for system require all users to change their system access passwords (or second component) at least every 90 days.

Ensured that the project team trained on all applicable Business and System specific SOPs including Good Testing and Good Documentation Practices

Worked with the Business users in prioritizing the defects and planning for enhancements.

Actively assisted in conducting Gap analysis and Risk assessment.

Prepared Remediation Plan and Validation Summary Report.

Work Authorization:

US Citizen

Education:

Bachelors in computer science and engineering

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