Summary
Overview
Work History
Education
Skills
Software
Certification
Timeline
Generic
Lakshmikanth S

Lakshmikanth S

Senior Associate in GxP Validation
Bengaluru,KA

Summary

Accomplished Senior Validation Specialist at Cognizant Technologies, adept in computer system validation/Assurance and fostering teamwork. Excelled in enhancing equipment efficiency and validation processes, achieving significant cost savings. Skilled in ISO standards and problem-solving, consistently met tight deadlines and led cross-functional teams to ensure regulatory compliance and project success.

Overview

11
11
years of professional experience
2
2
Certifications
1
1
Language

Work History

Senior Validation Specialist

Cognizant Technologies
03.2022 - Current
  • Spearheaded root cause analysis investigations following deviations, leading to corrective actions that mitigated future risks.
  • Enhanced equipment efficiency by conducting thorough validations, resulting in reduced downtime.
  • Improved validation processes by implementing risk-based strategies and advanced techniques.
  • Achieved cost savings through efficient planning and execution of validation projects, minimizing rework requirements.
  • Established strong relationships with key stakeholders, facilitating open communication channels for successful project outcomes.
  • Ensured regulatory compliance with meticulous documentation of all validation activities and results.
  • Mentored junior team members, fostering a culture of knowledge-sharing and professional growth within the department.
  • Developed robust testing protocols that contributed to improved product quality and consistency across production lines.
  • Implemented effective change management strategies during equipment modifications or upgrades, ensuring smooth transitions with minimal impact on operations.
  • Met tight deadlines to satisfy client demands and project timelines.
  • Collaborated with cross-functional teams for identification and resolution of validation issues.
  • Trained and guided onsite and offshore team members in quality assurance standards, policies and procedures.
  • Organize the status meetings and send the Status Report (Daily/Weekly) to the Customer
  • Worked on various modules like Stability Management, Environment Monitoring, Inventory Management, Batch Management, Sample Management, and Interfaces like HLEE, LMES and MuleSoft
  • Identified test scenarios and developed scripts for all modules mentioned above in ALM.
  • Provided required documents adhering to GDP standards.
  • Participated in interviews, induction, training, and performance evaluation of all QA Team members.
  • Involved in the Planning, Scheduling, reviews, estimation, monitoring and reporting of all the testing engineers' activities in the absence of lead.

Validation Specialist

Sutherland Global Service
12.2018 - 02.2022


  • Managed change control initiatives ensuring that all system modifications underwent proper revalidation before implementation into production environments.
  • Optimized resource allocation by prioritizing critical validations based on business needs and regulatory requirements.
  • Performed gap analyses between existing practices and required standards leading to the development of targeted action plans for compliance achievement.
  • Improved validation processes by implementing risk-based approaches and streamlining documentation.
  • Led the training of junior team members on validation principles and techniques, fostering a culture of continuous learning within the organization.
  • Ensured adherence to industry best practices by staying current on relevant guidelines such as FDA 21 CFR Part 11
  • Collaborated with cross-functional teams to ensure timely completion of validation projects, meeting regulatory requirements.
  • Involved in Requirements and Technical design documents review process and providing the inputs.
  • Executed various test activities pertaining to software testing includes Test Strategy, Test planning, Test effort estimation, Test management, Test environment Setup and defect management.
  • Prepared and executing the Functional, system and Regression testing test cases.
  • Delivered detailed artifacts such as Pre and Post Approval reports, bug reports and status reports.


Software Test Engineer

LG Soft India
08.2015 - 09.2018
  • Completed in-depth usability testing on Android mobile devices and Android applications.
  • Enhanced product reliability through thorough functional, regression, and performance testing.
  • Managed defect tracking systems, ensuring accurate documentation of issues for efficient resolution.
  • Optimized test coverage with risk-based analysis techniques, focusing on high-impact areas of the application.
  • Identified and tracked software defects and supported developers in resolving problems by completing additional tests.
  • Reviewed requirements, specifications, and technical design documents to provide timely and meaningful feedback.
  • Participated in available trainings to improve software knowledge.
  • Collaborated with cross-functional teams to identify system requirements and develop effective test strategies.
  • Streamlined testing processes by developing reusable test scripts and templates.
  • Facilitated knowledge sharing sessions on latest testing techniques, elevating team capabilities.
  • Coordinated cross-functional teams during end-to-end testing phases, ensuring comprehensive coverage.

Software Test Engineer

Collabera Technologies Private Limited
09.2014 - 05.2015
  • Identified critical bugs and worked closely with developers to ensure timely resolution, resulting in a more stable product.
  • Wrote and optimized test cases to maximize success of manual software testing with consistent, thorough approaches.
  • Enhanced product reliability through thorough functional, regression, and performance testing.
  • Designed testing scenarios for usability testing.
  • Optimized test cases to maximize success of manual software testing.
  • Managed defect tracking systems, ensuring accurate documentation of issues for efficient resolution.
  • Exceeded client expectations through exceptional attention to detail in identifying potential defects before release.
  • Implemented continuous improvement initiatives within the QA department, leading to increased accuracy in defect detection.
  • Collaborated with cross-functional teams to identify system requirements and develop effective test strategies.

Software Testing Trainee

Ikontel Pvt Ltd
08.2013 - 09.2014
  • Assisted in the design and implementation of smoke tests as part of build validation efforts.
  • Executed Fractional and UAT tests manually to assess application response times under heavy load conditions.
  • Conducted thorough compatibility testing across multiple platforms and devices, ensuring seamless end-user experience.
  • Collaborated with development team for timely bug resolution, improving overall product performance.
  • Performed regression testing after each release, maintaining a high standard of software functionality.
  • Enhanced software quality by executing test cases and reporting defects.
  • Verified fixes implemented by developers, ensuring a smooth user experience.

Education

Bachelor of Science - Computer Science

Pragati Collage of Science And Management Studies
Chintamani, India
04.2001 -

Skills

Test execution

Software

HP/ Micro Focus ALM

JIRA

CDOCS

CQ

Certification

ISTQB Foundation level

Timeline

Certified Scrum Master

11-2023

Senior Validation Specialist

Cognizant Technologies
03.2022 - Current

Validation Specialist

Sutherland Global Service
12.2018 - 02.2022

ISTQB Foundation level

06-2018

Software Test Engineer

LG Soft India
08.2015 - 09.2018

Software Test Engineer

Collabera Technologies Private Limited
09.2014 - 05.2015

Software Testing Trainee

Ikontel Pvt Ltd
08.2013 - 09.2014

Bachelor of Science - Computer Science

Pragati Collage of Science And Management Studies
04.2001 -
Lakshmikanth SSenior Associate in GxP Validation