Manasa Goli
Chicago
Summary
Accomplished Software Quality Assurance Engineer with a proven track record at Sysmex, excelling in risk management and test case management. Expert in developing validation strategies and enhancing product readiness standards, while fostering team collaboration to drive quality improvements. Adept at troubleshooting and optimizing test documentation for compliance with regulatory requirements.
Overview
13
13
years of professional experience
1
1
Certification
Work History
Software Quality Assurance Engineer /Document Control Specialist
Employer: Forbes, Client : Sysmex
Chicago
08.2024 - Current
- Ensured that all documentation related to validations is properly maintained according to established procedures.
- Provided guidance on regulatory requirements for various types of validations.
- Collaborated closely with cross-functional teams including Quality Control, Manufacturing, R&D, throughout the lifecycle of a project.
- Documented results of validation activities in accordance with FDA guidelines.
- Participated in internal audits and inspections related to validations programs or other quality assurance initiatives.
- Provided technical support to other departments for troubleshooting, debugging and validation of software applications.
- Managed daily activities related to defect tracking, resolution and retesting processes.
- Developed and implemented document control procedures to ensure compliance with company standards.
- Assisted with the development of new documentation systems, processes, and templates.
- Ensured all controlled documents (SOPs, protocols, work instructions, and batch records) were reviewed, formatted, routed, and approved within tight timelines to meet project and audit deadlines.
- Conducted regular audits of documents for accuracy, consistency, and completeness.
- Maintained strict compliance with 21 CFR Part 820, ISO 13485, and internal QMS procedures, ensuring audit readiness at all times.
- Reduced document review and approval cycle time by 70% by proactively coordinating with cross-functional teams (Regulatory Affairs, Clinical Affairs, Quality Control, Warehouse, Lab, etc.).
- Managed the release of confidential information in accordance with legal regulations.
- Responded quickly to requests from internal customers regarding the status of their documents or projects.
- Analyzed existing workflow processes related to document control operations and identified opportunities for improvement.
- Maintained all documents in a secure electronic database.
- Ensured that documents met all quality requirements before being released for distribution or use.
- Tracked changes to documents according to established policies and procedures.
- Created periodic status updates related to document control activities and provided feedback to project teams.
- Evaluated various forms of documentation and reports for accuracy and completeness, identified deficiencies and advised on appropriate corrective measures to improve information details or processes.
- Supported Change Control processes by ensuring the correct and timely routing of change requests, impact assessments, and implementation documentation.
- Excelled in fast-paced environments, balancing multiple priorities without compromising accuracy or quality.
Lead Validation Engineer/ Quality Engineer
Employer: Wipro, Client : Philips
Chicago
11.2023 - 07.2024
- Developed and executed validation deliverables including validation plans, test protocols, and traceability for GxP systems.
- Conducted thorough document analysis, classifying them per standards for effective validation.
- Reviewed and updated SOPs, test cases, and validation deliverables like IQs, OQs, and PQs.
- Documented defects and deviations accurately while coordinating with internal and external teams to resolve issues efficiently.
- Led quality reviews and ensured compliance with company standards throughout validation activities.
- Performed root cause analysis and defect tracking to enhance GxP system reliability.
- Mentored stakeholders and cross-functional teams on SOPs, policies, and regulatory standards.
- Streamlined support processes to enhance efficiency and prioritize tasks across teams.
- Identified areas where process improvements could be implemented based on validation data collected during execution phase.
- Maintained accurate records of all tests performed throughout the entire life cycle of a product or system.
- Ensured proper implementation of change control procedures when needed.
- Led training sessions on best practices for executing validation activities.
Validation Analyst
Employer: ECQR Inc.,& Wipro Client : Abbvie
Chicago
11.2021 - 10.2023
- Executed Agile and Scrum frameworks, achieving timely releases and well-structured sprints.
- Developed comprehensive Validation Strategy and Validation Plan for SAP ERP System implementation.
- Collaborated closely with cross-functional teams throughout various stages of software development lifecycle.
- Provided support throughout the entire life cycle of validation projects including planning, execution, tracking and reporting phases.
- Assisted in the development of test scripts and automation frameworks used for software quality assurance purposes.
- Ensured that all validation processes were compliant with applicable regulations.
- Documented testing procedures to guide testers and facilitate future assessments.
- Recommended enhancements to developers, improving software performance and usability.
- Analyzed integration issues, reported vulnerabilities, and proposed actionable improvements.
- Monitored bug resolution progress, tested fixes, and provided QA insights to developers.
- Reviewed automated test scripts in TOSCA to optimize efficiency of repetitive testing tasks.
Validation Analyst
Employer: Clappone, Client: Takeda
Chicago
05.2020 - 11.2021
- Delivered quality IT systems through collaboration with global cross-functional teams.
- Reviewed and approved Standard Operating Procedures for validation protocols.
- Generated and reviewed CSV deliverables ensuring compliance with 21 CFR Part 11 and GxP regulations.
- Executed validation protocols, reports, and commissioning documents for bio-pharmaceutical equipment and facilities.
- Designed user and functionality requirements for enterprise software aligned with regulatory standards.
- Prepared test data and executed regression test scripts using HP ALM/Quality Center.
- Developed weekly status reports to communicate project progress effectively.
- Maintained updated records related to validated systems, applications, products in accordance with company's document control policy.
- Implemented corrective action plans when discrepancies were found during the validation process or post-release phase.
- Performed system integration tests to verify the accuracy of data exchange between integrated applications.
- Assisted in developing training materials for end users regarding use of validated systems, applications, products.
- Analyzed user requirements, specifications and technical design documents to create detailed, comprehensive and well-structured test plans.
Quality Assurance Engineer
Tata Consultancy Services
02.2012 - 10.2014
- Authored, reviewed, and approved Computer Systems Validation deliverables per 21 CFR Part 11 and GxP regulations.
- Collaborated across USA, Europe, UAE, and India in regulated environments to meet client needs.
- Facilitated requirements gathering and design review sessions with stakeholders and technical teams.
- Assisted IT in developing SLC documents for Change Management and IT Compliance procedures.
- Conducted gap analysis to assess system infrastructure compatibility with new business requirements.
- Executed validation activities for applications and manufacturing software using HP ALM.
- Managed HP ALM and Atlassian JIRA tools, overseeing workflows and defect lifecycle processes.
- Enhanced report processing time by twenty-five percent through data pruning techniques.
- Evaluated existing processes within the Quality Assurance department and recommended improvements where necessary.
- Met project scope and delivery dates by planning optimal testing schedules.
- Created and maintained database of common and known testing defects.
Education
Bachelor of Science - Computer Science
Jawaharlal Nehru Technological University
Kakinda, India05-2011
Skills
- Tools: qTest, JIRA, HP-ALM, Kneat, Confluence, ValGenesis, MS Office Suite (Word, Excel, PowerPoint, Outlook), MS Visio, MS Project, Veeva Vault, TrackWise
- Methodologies: Agile, Waterfall, V-Model, Spiral
- FDA regulations: 21 CFR Part 11 (electronic records, signatures), 210-211 (cGMPs)
- sap s/4 hana
- Risk management
- Manual testing
- Test case management
- User acceptance testing
- Testing script development
- Defect documentation
- Test execution
- Troubleshooting and resolution
- Product readiness standards
- Functional testing
- QMS
- Quality assurance
- Test plan optimization
- Test strategy development
- Software development life cycle
- Regression testing
- Test documentation
- Requirements analysis
- Team collaboration
- Multitasking capacity
- Task prioritization
- Validation deliverables: project/validation plan, project/validation summary, RTM, URS, FRS, IQ, OQ, PQ protocols, SOPs/work instructions
- FDA compliance
- Key performance indicator tracking
- Document control
- Regulatory compliance
- Cross-functional collaboration
- Document analysis
- Audit readiness
Certification
- ITIL Foundation Certificate in IT Service Management
- Sun Certified Java Developer 1.6
Accomplishments
- Completed requirements analysis including the evaluation of systems specifications for client two weeks ahead of deadline.
- Streamlined QA/QC process and identified/highlighted critical defects/risks which increased efficiency and reduced new product rollout time by one week.
- Collaborated on client engagement strategy to drive entry into risk-driven project methodology, improving accuracy of project definition, sizing estimates, and yearly resource budget planning.
- Improved client relationships and project predictability through shared business and technical perspectives, agreed project roles, risk assessment and time-boxed delivery.
- Improved quality of documentation by thoroughly checking for accuracy, clarity, completeness, and consistency.
- Identified critical documentation errors (e.g., incorrect revision histories, missing approvals, outdated forms, incorrect references) that could have led to FDA non-compliance—thereby mitigating regulatory risk.
- Demonstrated a very keen eye for detail, consistently catching discrepancies or inconsistencies during document reviews that others overlooked.
- Played key role in successful launch/upgrade of high-quality products/system and received multiple customer appreciations for possessing a great attention to detail and delivering 100% accurate documentation/product/system.
Timeline
Software Quality Assurance Engineer /Document Control Specialist
Employer: Forbes, Client : Sysmex
08.2024 - Current
Lead Validation Engineer/ Quality Engineer
Employer: Wipro, Client : Philips
11.2023 - 07.2024
Validation Analyst
Employer: ECQR Inc.,& Wipro Client : Abbvie
11.2021 - 10.2023
Validation Analyst
Employer: Clappone, Client: Takeda
05.2020 - 11.2021
Quality Assurance Engineer
Tata Consultancy Services
02.2012 - 10.2014
Bachelor of Science - Computer Science
Jawaharlal Nehru Technological University
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