HP/ Micro Focus ALM
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
ISO standards
Cleaning validation
Computer system validation
Change control
Protocol development
Validation planning
Software validation
Teamwork and collaboration
Problem-solving
Test case development
Testing management
Process validation
Validation standards
Validation testing
Software testing
SM LIMS
Medical Device Validation
Software
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 -