MADHU VUPPU
Validation Consultant
Bangalore
Summary
Detail-oriented highly skilled IT CSV Specialist with over 15 plus years of experience in Validating Computer Systems in regulated industries. Proficient in ensuring compliance with 21 CFR part 11, GxP, and GMP regulations. Adept at managing all phases of Software Development Life Cycle (SDLC) implementing Validation methodologies, Strong background in risk assessment, documentation and Quality Assurance.
Overview
21
21
years of professional experience
Work History
IT CSV Senior Specialist
Xellia Pharmaceuticals PVT LTD, Bangalore
04.2024 - Current
- Develop and execute Validation Plans, Protocols, and reports for Computer System in Compliance with regulatory requirements.
- Conduct Risk Assessments and ensure documentation meets quality standards.
- Collaborate with project teams to deliver Validation deliverables on time
- Coordinating with cross functional organizational teams in assisting of developing, work instructions, Operating System Procedures, Polices etc.
- Conducted Audit and inspections to ensure compliance and Gxp regulations
- Leading CCB(Business Applications & Infrastructure Changes) and Governance Board Meetings.
- Participated in Audit with PWC and Gilead Teams.
- Developed and Maintained Standard Operating Procedures (SOP’s) for validation Process.
- Tools: Decision Focus(APM), Track wise(QMS), MF ALM, myProcess(DMS), ITSM(Service Management), LMS(Learning Management)
VALIDATION CONSULTANT
Tata Consultancy Services, Bangalore
BANGALORE
04.2022 - 03.2024
- Followed Computer System Validation CSV Master Plan to Author, review and approve CSV deliverables for systems as per Gxp, GCP, GMP, cGMP FDA Assessment.
- Authored, reviewed and approved CSV deliverables, Validation Project Plan, URS, TM, IQ, OQ, PQ, Period Audit Report, System Risk Assessment, Decommissioning Report, and Validation Summary Report.
- Reviewed and followed SOPs to help the business process in line with FDA regulations.
- Organized and attended meetings to discuss the status of the Projects.
- Initiating Initial Impact Assessment and Final Impact Assessments
- Involved in risk analysis of the requirements with the team.
- Verified Audit logs and user privileges.
- Validated the process reviewed qualification documents IQ, OQ & PQ.
- Coordinating UAT activities (IPQ) with END users.
- Communicate the daily operations of the Validation team to the management and assure that all the deliverable’s is generated, reviewed and approved within the predetermined timeliness.
- TOOLS : MF ALM, JIRA, Service now, IRAAM+, GMP-Inventory, VEEVA QualityDocs.
TEAM LEAD- Quality Control
Cenduit India Services (An IQVIA BUSINESS) Bangalore
03.2008 - 09.2017
- In charge of the Managing Compliance Team and qualifying projects involving process, Facilitates study activities. Ensure full compliance with relevant regulations, guidelines and requirements.
- As a Team Lead, I am responsible for the Complete Management & Delivery of the Projects with Quality in my team. Working as a Technical Base between Projects managers and Team members.
- Ensuring all QC Gating’s are meeting as per project plan.
- Hands-on experience in validation and testing of IRT systems supporting clinical trial randomization, drug supply management, and subject enrollment.
- Executed functional and UAT testing for IRT workflows including subject randomization, visit scheduling, dose assignment, and emergency unblinding.
- Tested drug supply and inventory management features, including shipment creation, depot-to-site distribution, and accountability tracking.
- Verified randomization schemes and stratification logic to ensure protocol adherence and accurate treatment allocation.
- Worked on validation and testing of eCOA applications to ensure accurate and compliant capture of patient-reported outcomes (PRO), clinician-reported outcomes (ClinRO), and observer-reported outcomes (ObsRO).
- Conducted testing and validation of eConsent systems used for subject enrollment and informed consent in clinical trials.
- Validated study-specific consent content, version control, and controlled document updates
- Performed system validation and testing of EDC platforms used for clinical trial data collection and management.
- Executed CRF testing including edit checks, derivations, field validations, and visit schedules.
- Coordinating UAT activities with END users.
- Participating in Table Review meetings to discuss the build of the study and parallel discussing the scenarios required to be covered in the test plans.
- Reviewing and approving of Validation deliverables for every study and every Change requests.
- Involved in reviewing Traceability matrix and Test summaries.
- Handling the Team of 12 QC Analysts.
- Solving technical problems of the team during the course of work.
- Maintaining the Bug Reports and tracking the status of Bugs before clearing each QC Gating
- Providing accurate and timely updates to project managers and to the study team on Projects progress on a periodic basis.
- Working with the Development team & Validation teams to assure test plans cover the new functionalists accurately
- Re-engineering SOP’s and Creating SOPS.
- Deviations, CAPA Management.
- Creating and Authorizing Templates.
- Quarterly participating in strategic planning meetings.
- Setting goals to the team members and conducting appraisals.
- Study Audits.
- Participating in Impact review meetings for Change requests.
- TOOLS : JIRA, ICCM, CR-Tracker, SharePoint.
QA ENGINEER
Sk Technologies LLC, Bangalore
11.2004 - 02.2008
- Worked in a team of 4 Quality Assurance team members and coordinated them in Testing, Auditing and Compliance.
- Assisting project team in the Process Deviation and Tailoring wherever required
- Analyzing Metrics on compliance.
- Involving in the Quality Control (QC) Process and Internal Audits
- Develops and maintains good communications and working relationships with teams and external clients.
- Performs other duties as required.
Education
B.E - Computer Science & Engineering
University OF Madras
ChennaiDiploma - Computer Technology
Department of Technical Education
ChennaiSkills
Computer system Validation
21 CFR Part 11 Compliance
GxP and GMP Regulations
IRT, eCOA, eConsent
ERP applications
IT Infrastructure
Change Board
Governance
Audit Support
Gap Assessments
Periodic Reviews
AWARDS
Pursued 4 Best Performance Awards at Cenduit India Services, Bangalore., Two cheers Awards., Two QSTAR Award for the year 2012 & 2013, Pursued Standard of Excellence Awards from CEO, Cenduit India Services for Intercia client project in 2012., Pursued Standard of Excellence Cheers Awards for Team IRT Express (Base Study) from, Cenduit Inc. in 2010., Winner of the Spot Award in Aug 09 for Transferring knowledge to the team on reducing time lines for Change Requests., Winner of the Spot Award for giving idea for migrating checklists to the ICCM for timely follow ups., Pursued Team of the Year Award in 2015
Timeline
IT CSV Senior Specialist
Xellia Pharmaceuticals PVT LTD, Bangalore
04.2024 - Current
VALIDATION CONSULTANT
Tata Consultancy Services, Bangalore
04.2022 - 03.2024
TEAM LEAD- Quality Control
Cenduit India Services (An IQVIA BUSINESS) Bangalore
03.2008 - 09.2017
QA ENGINEER
Sk Technologies LLC, Bangalore
11.2004 - 02.2008
Diploma - Computer Technology
Department of Technical Education
B.E - Computer Science & Engineering
University OF Madras