GANGA VEERA BHADRAM Miriyala

• 11 + years of Experience in Life Sciences, Specializing in Computer System Validation (CSV/CSA), IT Service Management Operations, Quality & Compliance, SaaS/Cloud Platforms, Risk Management and Periodic Reviews.
• Experienced in Automation & Digital Transformation Projects, Enterprise Applications (MES, SAP, DMS, Trackwise, E Val, EPQR), Laboratory Systems, Manufacturing IT/OT integrations.
• Proven expertise in Audit Readiness, Supplier Management and GAP Assessment.
• Skilled in ensuring compliance with 21 CFR Part 11, EU Annex 11 & GMAP 5

• US FDA 21 CFR Part 11
• EU Annex 11
• GAMP 5
• ISO 13485
• ALCOA+

Applications:

• MES - Syncade (Emerson) & Delta V
• ValGenesis (E Val)
• SAP System (ECC & S/4 HANA)
• Electronic Document Management System (EDMS)
• LIMS
• TrackWise (Quality Management System)
• Electronic Product Quality Review (EPQR)
• Elog/ELN & RMS
• UiPath, HVR and Snap logic
• Service Now & LMS

SCADA & Manufacturing Systems:

• EMS & BMS Systems
• LINE SCADA
• ICDAS
• Water System
• Lyophilizer
• Autoclaves
• Compression Machines

Laboratory Systems:

• Chromatography Data Systems (Empower, LabSolutions, OpenLab etc.)
• HPLC & GC
• UV Spectrophotometer
• FTIR
• Auto titrator

• Extensive experience in developing and executing validation deliverables including GxP Assessments, Validation / Test Plans (VP/TP), Functional Risk Assessments (FRA), Qualification Protocols (IQ, OQ, PQ, AQ, IOQ, IPQ, MQ), 21 CFR Part 11 Checklists, RTM, Validation Summary Reports (VSR).
• Managed and delivered CSV implementations for Laboratory (Servers based Empower, LabSolutions and other Standalone Software’s of UV, IR etc.), Manufacturing and Enterprise systems including TrackWise, DMS, and MES within the Life Sciences domain.
• Led IT Service Management (ITSM) and CSV projects, ensuring regulatory compliance and audit readiness across enterprise applications.
• Governed and applied ITIL processes (Incident, Change, Release Management) to support system stability and compliance objectives.
• Collaborated with IT Business Analysts, Delivery Leads, and QA teams to ensure readiness across functional testing, deployment planning, and rollout activities for multi-site environments (US, Singapore).
• Authored and maintained SOPs and validation documentation ensuring alignment with GxP requirements and ITIL practices.
• Managed Weekly and Quarterly ServiceNow releases and enhancements to ensure compliance alignment and code deployment.
• Reviewed and approved validation documentation and QMS documents to ensure alignment with regulatory, quality, and business requirements.
• Investigated and resolved deviations and defects during qualification and validation activities using CAPA methodology to prevent recurrence and improve compliance.
• Led and Managed validation teams to ensure end-to-end system validation aligned with customer expectations and business objectives.
• Led Risk Assessments to identify and mitigate risks related to data integrity, product quality, patient safety, system security, and compliance.
• Coordinated cross-functional project teams (Business, QA, IT or Vendor) and ensured timely communication of project status and coordinating/delivering validation deliverables.
• Performed Periodic Reviews of GxP computerized systems to ensure continued compliance, data integrity, and fitness for intended use.
• Managed Change Control, CAPA, and Deviation processes within QMS frameworks, evaluating validation impacts and ensuring appropriate actions were completed.
• Performed GAP Analysis / Assessments for Legacy Systems to ensure intended use and regulatory requirements.
• Supported client audits and regulatory inspections by providing validation evidence and compliance documentation.
• Led client engagement for Computer System Validation initiatives, ensuring effective coordination among cross-functional teams, audit preparedness, and timely delivery of systems in regulated environments.
• Participated and provided support GxP regulatory audits and internal audits as needed. Having experience on performing the internal audits.
• Responsible for Preparation of Data Migration Protocols & Software / System Retirement Protocols as per requirement.
• Responsible for performing Supplier Assessments for computerized systems to evaluate that the vendor maintains an Operational Structure and Quality Management Procedure / Standards, Services etc.
• Having experience on Audit Trail Review for all Computerized Systems as per Schedule.
• Coordinating with User Departments (Business Users), Functional department, Technical Team and supporting functions for preparation and execution of Validation Documents as per the Business / Client requirements.

EQUIPMENT / INSTRUMENT QUALIFICATIONS:

• Managed IT/OT integration projects including EMS, BMS, Line SCADA systems to ensure systems meet regulatory, operational, and quality requirements.
• Led risk assessments, FAT/SAT activities, and system verification to support equipment readiness and compliance.
• Collaborated with engineering, End User, and QA teams to troubleshoot issues and ensure successful qualification outcomes.
• Executed Commissioning and Qualification (CAQ) Protocols (IQ, OQ or IOQ) for PLC with HMI/SCADA/IPC based systems.
• Supported change control activities and maintained documentation for audit readiness.
• Managed vendor coordination during equipment installation, testing, and qualification phases.
• Ensured timely execution of validation deliverables to meet project timelines and regulatory expectations.