Mahesh M

About Mahesh M

With over 10 years of IT experience in the Life Sciences and Pharmaceutical domain, I specialize in implementing and supporting Quality Management Systems (QMS) using TrackWise. My expertise spans system configuration, integration, validation, and compliance management under GxP, 21 CFR Part 11, and GAMP 5 frameworks.As a Technical Lead, I have successfully led cross-functional teams to deliver QMS solutions across modules such as Complaints, CAPA, Audit, Deviation, and Change Control. My technical foundation includes Java, Spring Boot, iBatis, Hibernate, and Web Services development — enabling seamless integration between TrackWise and enterprise systems like SAP and document management platforms.Beyond implementation, I focus on aligning technology with business objectives to enhance compliance and operational efficiency. I have overseen migration projects, authored validation deliverables (IQ, OQ, PQ, Design Documents, URS, FRS), and ensured full audit readiness across multiple regulated environments. I am also skilled in SAP Crystal Reports for QMS analytics and KPI monitoring, improving data visibility for management reporting.In addition to TrackWise, My collaborative work with QA and validation teams ensures that every change or configuration is properly validated and documented to meet compliance and quality standards.I take pride in fostering team collaboration and driving measurable impact. My leadership has led to process automation that reduced manual effort by 50%, streamlined change management cycles, and improved service delivery KPIs across projects.I’m passionate about digital transformation in Quality and Compliance systems, helping Life Sciences organizations modernize QMS processes, strengthen data integrity, and enhance regulatory inspection readiness.Specialties:TrackWise| QMS Implementation | CSV | GxP | 21 CFR Part 11 | Web Services | SAP Crystal Reports | Validation & Documentation (IQ, OQ, PQ)| Audit Readiness | Life Sciences IT Consulting

Experience

1. Technical Lead

   Tata Consultancy Services

   Apr 2023 — Present · Bengaluru, IN

   Tata Consultancy Services (TCS)| Apr 2023 – Present | Bengaluru, IndiaAs a Technical Lead, I lead end-to-end TrackWise Quality Management System (QMS) implementation and support activities for major Life Sciences clients. I manage a team of five professionals responsible for configuration, integration, and validation under GxP and 21 CFR Part 11 compliance.I oversee system design, development of Java-based Web Services, and the migration of legacy applications into Microservices (Spring Boot) architecture. I also collaborate with cross-functional teams to align technical solutions with business and compliance objectives.Key Highlights:Automated login account creation, reducing manual effort by 50% and improving traceability.Streamlined Product Record update process, cutting turnaround time by 25%.Authored and reviewed validation deliverables (IQ, OQ, Design, and Requirements) ensuring audit readiness.Created and optimized SAP Crystal Reports and SQL data extractions to enhance reporting accuracy.Consistently maintained 100% KPI compliance and zero audit findings across multiple projects.

Education

• Bangalore University

  Bachelor's degree, Computer Science

  2011 — 2014