Hemanathan Kumaravelu

• Demonstrated strong organizational and time management skills while managing multiple projects.
• Documented entire validation process, noting changes or alterations completed.
• Analyzed pre-release software titles for compliance with User Requirement Specifications (URS), referring any deficits to appropriate personnel.
• Participated in system design and commissioning phase, interfacing directly with clients to ascertain clear, concise milestones for integration into development timelines.
• Collaborated on Standard Operating Procedure (SOP) development, incorporating input from stakeholders team to reduce liability and enhance successful deployments.
• Explained highly complex information in terms easily understood by non-technical personnel.

• Developed computer system validation related content, controlled documents to support the start-up, validation, operation and maintenance of site GMP computerized system for project qualification plans and protocols.
• Authored, reviewed and approved the validation plans, computer validation protocols and reports.
• Involved GAP analysis, Root Cause Analysis, Corrective and Preventive Actions (CAPA) reporting, handling and closing of identified defects and findings.
• Ensured the system are compliant with current corporate computerized validation polices and legislative requirements.
• Ensured all tools, templates and materials are readily available and up to date.
• Support change management activities for cGMP computer systems and other related activities.
• Provided computer system validation related response to inspectors.

Quess Corp (Philips)

Apr 2019 to Feb 2020

Contract Change to Mind tree

Mar 2020 to Dec 2021

Project – Philips, Central Archiving

• Manage Computer System Validation projects of GxP application according to United States Food and Drug Administration (FDA) guidance, 21 CFR 11, 21 CFR Part 210, EU Annex 11, HIPAA, ICH and ISPE Good Automated Manufacturing Practice (GAMP) guidance.
• Perform validation based on established best validation practices and standard operating procedures.
• Study and Analysis of business requirements. Make sure GxP guidelines are followed stringently.
• Consult project team on quality management and involve in defining the validation strategy, risk management for GxP systems.
• Perform GxP assessment, and data integrity assessment and propose mitigation activities.
• Prepare validation plan, risk management plan and perform functional risk assessment per applicable compliance with GAMP 5 quality risk management and other predicate rules pertaining to the concerned regulatory agency (FDA, EMEA, PMDA).
• Guide and mentor validation engineers in drafting the qualification protocols (Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ), Data Migration Qualification (DMQ) and Disaster Recovery Qualification (DRQ)) for validating computer system software configuration, business functionalities, disaster recovery and data migration scenarios.
• Drive end to end change management to ensure compliance against the standard operating procedures and policies leveraging quality management software.
• Prepare validation summary, OQ/PQ/IQPQ/IQPR summary(s)
• Review and approve all system-related validation deliverables for end-to-end lifecycle including user requirement specification, functional requirement specification, risk assessment, design specification, OQ/PQ Protocols and test results/summaries, operations manuals and training manuals
• Support/guide and mentor validation engineers with project deliverables.
• Perform decommissioning of legacy GxP system.
• Qualify disaster recovery of GxP systems.
• Part of change control team review quality metrics and identify gaps and propose improvements.

• Participate in requirement gathering sessions and raised clarifications.
• Collaborate with Validation Team in authoring validation plan, risk assessment of finalized requirements. Created validation scenarios document with validation scenarios per risk assessment for finalized requirement.
• Author Qualification Protocols (Operation Qualification (OQ), (Performance Qualification (PQ), Data Migration Qualification (DMQ) and Disaster Recovery Qualification (DRQ))per approved validation scenarios.
• Execute Qualification Protocols (Operation Qualification (OQ), (Performance Qualification (PQ), Data Migration Qualification (DMQ) and Disaster Recovery Qualification (DRQ))after Change control team approval.
• Peer review executed Qualification protocols.
• Work as test coordinator for business testing.
• Prepare Requirements Traceability Matrix.
• Coordinate with validation lead and create deviation report in case of deviation and ensured its closure.
• Collaborate with validation Lead in validation summary report preparation.
• Maintain daily status tracker based on qualification activities.
• Document qualification results and defects identified during execution in accordance to SOP’s/ Good Documentation Practice

• Participate in requirement gathering sessions along with technical and BA teams.
• Handle query tracker and shared with client team (including technical and business teams) for clarifications.
• Maintain drug manufacturing system’s in validated state by performing Periodic review, Change Management, CAPA and Deviation Management from validation perspective.
• Involve in peer review of executed test cases.
• Prepare and update requirement traceability matrix.
• Involved in defect management and tracking defect till closure.
• Maintain daily status tracker based on testing activities and shared with client.

• Created plans for test method validation using research or field observations.
• Directed technical personnel in fabrication of testing and test control equipment.
• Established clear measurable goals and objectives for projects, prioritizing tasks for team members.
• Provided solutions to various technical problems of varying scope and complexity.
• Communicated technical information both verbally and in writing in simple terminology.
• Developed and maintained test and evaluation strategies for testing to show operational readiness and suitability with planned project decision points.