Shukla Sen
CSV Consultant
Kolkata
Summary
Experienced Computer System Validation (CSV) professional with 14 years in validation and quality assurance within regulated environments. Expertise in validating GxP systems, supporting regulatory audits, and implementing risk-based validation per GAMP 5. Committed to audit readiness and enhancing validation efficiency while delivering high-quality validated systems in global teams.
Overview
14
14
years of professional experience
Work History
Validation Lead
TCS
03.2012 - Current
- Directed project delivery with a focus on validation and quality assurance. Handled IQ, OQ, and PQ documentation to maintain thorough compliance records. Executed risk assessments to evaluate and address potential project risks. Formulated validation plans to ensure alignment with applicable regulations.
- Managed validation processes for OpCenter, once known as Camstar, installation including environment configuration and troubleshooting application issues
- oversaw team responsible for environment build and validation execution activities, ensuring adherence to quality standards
- Created and carried out effective test strategies, regression test suites, and quality control procedures to maintain compliance with standards.
- Coordinated efforts with development and client teams to design and authenticate workflows leveraging Opcenter Functional Modeler.
- Carried out comprehensive functional testing, regression testing, and system validation for numerous projects including upgrades and prototype implementations.
- conducted training sessions for new team members and peers on validation best practices and test management tools, enhancing team knowledge
Education
B.Tech - Applied Electronics and Instrumentation
Bengal College of Engineering & Technology
DurgapurHigher Secondary -
Carmel Convent
Secondary -
Carmel Convent
Skills
Validation methodologies
Siemens Opcenter expertise
Positive demeanor
Teamwork and collaboration
Customer service
Regulatory compliance
Test management tools
Experience with HP ALM
Accomplishments
- Led Computer System Validation (CSV) activities for GxP-regulated systems, including MES and enterprise applications, ensuring full compliance with FDA 21 CFR Part 11 and EU Annex 11
- Supported multiple internal regulatory audits, ensuring successful inspection readiness with no critical compliance gaps reported
- Contributed to defect reduction initiatives across validation and testing cycles, improving system stability and reducing recurring validation issues through structured root cause analysis and process improvements
- Played a key role in multiple MES/validation initiatives, supporting end-to-end lifecycle validation including planning, execution, and closure activities
- Implemented risk-based validation approaches (GAMP 5), improving validation efficiency and focusing effort on high-risk system functionalities
Personal Details
- Marital Status: Married
- Nationality: Indian
Timeline
Validation Lead
TCS
03.2012 - Current
B.Tech - Applied Electronics and Instrumentation
Bengal College of Engineering & Technology
Higher Secondary -
Carmel Convent
Secondary -
Carmel Convent