Muthumeenaa Muthiah
San Francisco,CA
Summary
Experienced healthcare professional with 9+ years of expertise in quality, compliance, CSV, and change management. Certified in IT service management (ITIL V4). Recognized by the CIO for successfully completing external audits with no findings. Skilled in ensuring compliance with 21 CFR part 11, ISO13485, ISO 9001, and GxP. Proficient in non-product computer software validation and risk-based approach. Effective at managing CAPA and monitoring IT Change/Release Management process. Experienced in reviewing and approving validation documents. Certified tester with 5 years of Agile, manual, and DB testing experience. Strong communication skills for requirements clarification and active participation in Release Management activities.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Advanced Business Analyst
Novo Nordisk
12.2021 - 04.2024
- Part of the digital quality GBS team
- Coordinate the IT Validation activities for IT systems/services/projects in NNQ GBS.
- Provide compliance consulting for the IT projects and deliver compliance deliverables with respect to CSV
- Co-ordinate Validation activities with System/Project Management, Suppliers and IT QA
- Participate in system releases as Validation SM
- Prepare IT Risk Assessment and drive the Risk assessment workshop seeking inputs from relevant participants.
- Identify GxP, non GxP projects and to register all the personal data used as per the GDPR.
- Prepare User requirements specification,O&M,Validation plan and report.
- Conduct Design Review meetings and coordinate with various stakeholders.
- Provide guidance to the IT System Subject Matter Expert on questions related to Computer System Validation
- Perform compliance related tasks including system documentation, review, and approval of CSV deliverables.
IT Quality Executive (Global)
WS Audiology-India (Internal Transfer)
01.2021 - 11.2021
- Same role and achievements as mentioned in my WS Audiology -Singapore experience below
IT Quality Executive (Global)
WS Audiology
04.2019 - 12.2020
- Prepare status report information and documentation for periodic regulatory audit requirements such as FDA, TUV, GxP, ISO 13485 etc
- Ensure that Non product computer software validation is conducted in accordance with 21 CFR part 11, ISO13485, ISO 9001 and GxP
- Liaise with external and internal auditors to provide all the documentations in accordance to the audit requirements
- Accept or reject the CAPA with the proper rationale and action plan to investigate and resolve the issue
- Manage the change request review and approval process with technical teams and business stakeholders that all impacted IT systems, infrastructure, and other relevant teams are aware of proposed change
- Provide support to aid in successful execution of IT Change/Release Management
- Monitor and govern compliance with the Change/Release Management process
- Educate the global IT team about the validation process that we need to be followed for any new or existing changes
- Ensure proper documentation in place based on risk based validation approach
- Ensure requirements full and architecture designs undergo reviews to proactively validate appropriate applicability
- Ensure that templates such as protocols and reports are created and maintained in accordance with validation process, based on the principles of GAMP and other relevant compliance needs
- Define and maintain IT Quality and Change/Release Management policy, processes, initiatives, and related full documentations as part of the overall IT and QMS compliance framework
- Expertise in coordinating with ERP team to get the finalized roles that the user can request for and feed into the role request system
- Initiated and worked with cross functional team in providing requirements, testing and validating the tool, Eflow-Role Request
Software Engineer - Verification and Validation
Siemens Healthcare Private Limited
07.2016 - 09.2018
- Company Overview: Siemens is demonstrating the benefits of this integration, which creates a comprehensive solution based on client-server technology
- In Siemens I was part of the Syngo Via project team
- Syngo Via is an imaging software for multimodality reading of clinical cases, which focuses specially on reading efficiency through automated case preparation and structured case navigation across multiple specialties, including cardiology, oncology, and neurology
- Expertise in end to end Manual testing of assigned module, Mainline testing of the new version, Regression testing of the hot fixes, System testing of upcoming version
- Expertise in compatibility testing on different Operating Systems
- Effective Communication with the product owner and Business Analyst to have a clear picture of the module to be tested
- Handle defects/new requirements as per customers (using the product) requirement
- Analyze the defect, write test case to validate it, find out Impact test cases related to the scenario, validate the defect and close the defect with required charm validation template
- Experience in writing new test cases based on the requirement/changes
- Update the test case document by creating a reuse copy of existing document, cloning it using PXI specification, making the required changes and reviewing with shared review process
- Guided the peer members with proper KT sessions about the components owned and vice versa
- Initiate and be a part of review meetings, Status meetings, Retrospective meetings
- Expertise in testing CT Scanner, MR scanner which are Deployment sets of Syngo Via products available in Global Markets
- Siemens is demonstrating the benefits of this integration, which creates a comprehensive solution based on client-server technology
Software Engineer
Hexaware Technologies
04.2015 - 12.2015
- Company Overview: PAREXEL International is a multinational life sciences consulting firm
- It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process
- Client Name: Parexel
- Utilized Agile methodology for testing health care domain project
- Effectively validated the clinical data from one source to another source (data validation)
- Experience in utilizing tools such as JIRA and Quality Center for tracking defects
- Utilized Informatica, UC4 for triggering the jobs and tracked the progress of it
- Effective knowledge in creating traceability matrix document and Status Reports
- Coordinated daily scrum call and biweekly sprint planning meeting
- Regular Coordination with On-site manager along with developer to evaluate scenarios and resolving issues
- PAREXEL International is a multinational life sciences consulting firm
- It conducts clinical trials on behalf of its pharmaceutical clients to expedite the drug approval process
Associate Software Engineer
Hexaware Technologies
06.2013 - 04.2015
- Company Overview: Citi Private Bank, a subsidiary of multinational banking conglomerate Citigroup, markets private banking services for wealthier clients
- Client name: Citi Private Banking
- Extensively experienced in GUI, Regression, System, Manual, Compatibility, Web and Agile testing
- Expertise in preparing test scenarios and test cases documents
- Supported nearly 40 members in resolving the defects, and deployed different packages using WebSphere(6.x/7)
- Excelled in setting up the new testing environments for different users using WebSphere(6.x/7)
- Collaborated with development teams on the application issues during release development changes
- Good exposure in release management activities
- Citi Private Bank, a subsidiary of multinational banking conglomerate Citigroup, markets private banking services for wealthier clients
Trainee
Global Talent Track
10.2012 - 01.2013
- Completed a specialized training program in software testing for a duration of 4 months as part of Hexaware On-boarding
Education
Bachelor of Engineering(B.E) - Electrical Engineering
Alagappa Chettiar College of Engineering And Technology
04-2012
Skills
- Computer System Validation
- Compliance
- Implementing Compliance - 21 CFR part 11,ISO13485, ISO 9001 and GxP
- CAPA
- Expertise in risk based validation approach-V model, GAMP
- Working on Internal and External Audits
- Defining and maintaining policies, processes, management manuals, WI and forms
- IT Governance
- Manual ,DB, Web, UI, Functional, System testing
- Release Management
Certification
- ITIL V4 Foundation Certificate, 01/21
- ISTQB Certified Tester, 01/21
Awards
- Quick Learner Appreciation, 01/21, For Agile project from the project lead.
- Appreciation from CIO, 01/21, For successful completion of the external audit with no findings.
Timeline
Advanced Business Analyst
Novo Nordisk
12.2021 - 04.2024
IT Quality Executive (Global)
WS Audiology-India (Internal Transfer)
01.2021 - 11.2021
IT Quality Executive (Global)
WS Audiology
04.2019 - 12.2020
Software Engineer - Verification and Validation
Siemens Healthcare Private Limited
07.2016 - 09.2018
Software Engineer
Hexaware Technologies
04.2015 - 12.2015
Associate Software Engineer
Hexaware Technologies
06.2013 - 04.2015
Trainee
Global Talent Track
10.2012 - 01.2013
- ITIL V4 Foundation Certificate, 01/21
- ISTQB Certified Tester, 01/21
Bachelor of Engineering(B.E) - Electrical Engineering
Alagappa Chettiar College of Engineering And Technology
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