Summary
Overview
Work History
Education
Skills
Languages
Software
Timeline
Generic
KEERTHI KUMAR

KEERTHI KUMAR

Computer System Validation
Bangalore

Summary

Results-driven Validation and Functional Subject Matter Expert (SME) with over 13 years of experience in developing and executing Validation Master Plans, with specialized expertise in Chromeleon and Empower CDS. Proven track record in authoring and approving validation protocols, managing end-to-end validation activities, and collaborating cross-functionally to ensure regulatory compliance and project success. Recognized for strong problem-solving abilities, sound decision-making, and effective communication skills.

Seeking a challenging opportunity to leverage my expertise in Empower and contribute to organizational growth through dedication, strategic thinking, and smart execution.

Overview

13
13
years of professional experience

Work History

CSV and Functional Consultant

CosMic-IT GmbH
12.2021 - Current
  • Currently serving as the Validation and Functional Consultant, collaborating with the Process Manager to oversee and validate global systems including Empower, QTrack, Tulip, VMS, and AWS GLMW infrastructure.
  • Developed and maintained Validation Master Plans (VMPs), Process Flow Diagrams, and Standard Operating Procedures (SOPs) to ensure compliance with regulatory requirements.
  • Successfully met tight project deadlines and client expectations by effectively managing validation activities and resources.
  • Proposed and implemented robust development and testing strategies to improve quality and ensure successful project outcomes.
  • Reviewed and maintained comprehensive technical documentation, including Configuration Management Plans (CMPs), for consistent reference and audit readiness.
  • Led risk assessment meetings, providing expertise on system impact, component criticality, data integrity, and regulatory compliance.
  • Trained and mentored both onsite and offshore team members in CSV best practices, quality standards, and procedural adherence.
  • Collaborated with cross-functional teams (QA, IT, Business, and Regulatory) to identify, analyze, and resolve validation and system-related issues.

Technical Lead-GRC

Happiestminds Ltd. (Client :Viatris/Pfizer)
09.2020 - 11.2021
  • Led the GRC-CSV (Governance, Risk & Compliance – Computer System Validation) team, including recruitment, team setup, and resource allocation across multiple client projects.
  • Conducted case study discussions to evaluate and plan resource allocation for new client engagements and validation initiatives.
  • Worked closely with the Global Program Manager as a Compliance and Project Coordinator, ensuring alignment between validation activities and overall project objectives.
  • Developed project plans and validation plans for multiple system implementation and upgrade projects.
  • Managed and facilitated Change Advisory Board (CAB) and pre-CAB meetings, and conducted stakeholder alignment calls with management.
  • Coordinated with Global Quality Assurance (GQA) teams on quality-related topics and validation strategy alignment.
  • Played a key role in audit readiness, supporting regulatory and internal audits by reviewing data and documentation to ensure completeness and compliance.
  • Assisted in drafting and managing audit responses and implementing Corrective and Preventive Actions (CAPAs).
  • Held overall responsibility for Computer System Validation (CSV), including development and execution of validation strategies, documentation, and lifecycle management.
  • Supported both software validation and infrastructure qualification, ensuring compliance with industry standards such as GAMP 5 and 21 CFR Part 11.
  • Reviewed and approved executed test cases, validation protocols, and reports, ensuring data integrity, traceability, and compliance with regulatory expectations.

Senior Validation Engineer

Ciber sites India Pvt. (Client : PHILIPS)
03.2019 - 09.2020
  • Held end-to-end responsibility for Computer System Validation, including validation strategy development, effort estimation, and active participation in Change Advisory Board (CAB) meetings.
  • Contributed to a range of validation activities including software validation, infrastructure qualification, periodic reviews, data migration, and system decommissioning.
  • Reviewed and approved test executions, validation protocols, and final reports, ensuring alignment with regulatory standards such as 21 CFR Part 11, EU Annex 11, and GAMP 5.
  • Conducted functional testing to validate system behavior against defined user and functional requirements.
  • Authored and executed multiple Validation Master Plans (VMPs) and validation protocols specifically for SAP and TrackWise systems.
  • Managed and validated operational changes within SAP and TrackWise, ensuring system integrity and compliance post-change.
  • Participated in cross-functional discussions to enhance and align organizational SOPs, with a focus on improving compliance, control, and quality standards.

Senior Executive

Syngene international limited, Biocon park
01.2017 - 12.2018
  • Contributed to software validation activities for systems such as LIMS and Chromeleon, including periodic reviews and coordination of instrument calibration processes.
  • Reviewed analytical method validation documentation for drug substances to ensure scientific accuracy and compliance with regulatory expectations.
  • Evaluated and approved technical documentation, including test protocols, validation reports, and stability study data, ensuring alignment with industry standards and regulatory guidelines (e.g., ICH, FDA, EU Annex 11).
  • Performed both functional testing and User Acceptance Testing (UAT) to verify that system functionalities met user and business requirements.
  • Authored and executed Validation Master Plans (VMPs) and validation protocols for various GxP systems.
  • Created and implemented Standard Operating Procedures (SOPs) aimed at enhancing process control, data reporting, and documentation consistency across projects.
  • Demonstrated strong ability to work independently and collaborating with QA, IT, and business stakeholders to meet project goals.

Executive-Validation

Anthem Bioscience pvt ltd
08.2016 - 01.2017
  • Contributed to software validation, periodic reviews, and instrument calibrations
  • Performed Analytical method validation for drug substance
  • Reviewed technical documents such as test protocols, validation reports and stability studies ensuring accuracy and compliance with regulatory requirements
  • Developed new analytical methods for more efficient and accurate testing of samples, resulting in faster turnaround times
  • Skilled at working independently and collaboratively in a team environment
  • Proved successful working within tight deadlines and a fast-paced environment
  • Conducted stability studies on formulations.

Associate -Quality

Mylan laboratory limited
07.2012 - 08.2016
  • Performed comprehensive analytical testing of raw materials, packaging materials, and finished goods (FG) at DPP and HGC manufacturing sites in compliance with GMP standards.
  • Executed and managed stability studies for FG, including compilation of detailed stability summary reports for regulatory submissions.
  • Led Technical Transfer and method transfer activities and conducted analytical method validations in alignment with ICH guidelines.
  • Managed and investigated Out of Specification (OOS), Out of Trend (OOT) results, deviations, and change controls, while ensuring strict adherence to Data Integrity (DI) principles.
  • Coordinated and authored audit responses and implemented effective Corrective and Preventive Actions (CAPAs) based on root cause analysis to ensure compliance and prevent recurrence.
  • Contributed to computer system validation (CSV) activities for Chromeleon and other GxP systems, including instrument qualification, system calibration, and periodic review processes.
  • Qualified and calibrated critical laboratory instruments including HPLC, GC, AAS, TOC analyzers, and pH meters, improving analytical reliability and compliance.
  • Acted as a key contributor during regulatory audits (USFDA, MHRA, TGA, and customer audits), ensuring audit readiness and timely documentation support.
  • Increased equipment effectiveness and uptime through regular preventive maintenance, reducing downtime and ensuring operational continuity.
  • Demonstrated strong cross-functional collaboration and time management by consistently meeting aggressive project timelines and client expectations.

Education

Master of Science - Chemistry

Kuvempu University
Bengaluru, India
06.2018

Bachelor of Science - Physics, Chemistry And Mathematics

Mysore University
Mandya
03.2012

Skills

  • Industry Experience: Over 13 years of experience in the Life Sciences and Medical Device industries, specializing in Quality, Compliance, and Computerized System Validation (CSV)
  • Empower & Chromeleon Expertise: Proven expertise as a Functional and Subject Matter Expert (SME) in Empower and Chromeleon chromatography Data Systems, including implementation, configuration, validation, and user support
  • Validation & Documentation: Extensive experience in authoring and reviewing key validation deliverables such as User Requirements Specifications (URS), Functional Specifications (FS), Validation Plans (VP), Qualification Protocols (IQ, OQ, PQ), Test Scripts (ST, CT, IT, UAT), Risk Assessments (RA), Summary Reports (VR, QR, DR, MR), and SOPs
  • Regulatory Knowledge: Strong familiarity with global regulatory frameworks and guidelines including 21 CFR Part 11, EU Annex 11, EU MDR, HIPAA, ISO 27001, ICH Q1/Q2/Q9, and ISPE GAMP 5
  • Audit Readiness: Experienced in preparing for and supporting audits by regulatory bodies such as USFDA, MHRA, TGA, and local authorities, as well as customer audits
  • Quality Tools & Methodologies: Well-versed in quality and compliance methodologies including ALCOA, Lean Management, 5S, QC tools, and both Agile and Waterfall project management methodologies
  • Data Integrity & Compliance: Deep understanding of data control, data integrity principles (ALCOA), electronic records/electronic signatures (ERES), and GxP compliance
  • Application Proficiency: Hands-on experience with tools and platforms such as ServiceNow, QCM TrackWise, HP ALM, ValGenesis, Doc-ER, LIMS, QDMS, MTC, Empower, and Chromeleon

Languages

English
Bilingual or Proficient (C2)
Kannada
Bilingual or Proficient (C2)
Tamil
Advanced (C1)
Telugu
Bilingual or Proficient (C2)
Hindi
Advanced (C1)

Software

ValGenesis

Chromeleon

Empower

TrackWise

Service Now

HP-ALM

LIMS

Doc-ER

Timeline

CSV and Functional Consultant

CosMic-IT GmbH
12.2021 - Current

Technical Lead-GRC

Happiestminds Ltd. (Client :Viatris/Pfizer)
09.2020 - 11.2021

Senior Validation Engineer

Ciber sites India Pvt. (Client : PHILIPS)
03.2019 - 09.2020

Senior Executive

Syngene international limited, Biocon park
01.2017 - 12.2018

Executive-Validation

Anthem Bioscience pvt ltd
08.2016 - 01.2017

Associate -Quality

Mylan laboratory limited
07.2012 - 08.2016

Master of Science - Chemistry

Kuvempu University

Bachelor of Science - Physics, Chemistry And Mathematics

Mysore University

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KEERTHI KUMARComputer System Validation