Rohini Thiagarajan
Chennai
Summary
Experienced Validation/Quality Specialist with 12 years in CSV/ CSA for international pharma companies. With a proven track record at Pharma industries I excel in leading validation activities and ensuring regulatory compliance. My expertise in risk-based validation approaches and strong leadership skills have significantly enhanced clinical system efficiencies. I adeptly manage end-to-end validation deliverables, leveraging my knowledge in GAMP 5 standards and Agile processes.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Senior Quality Specialist
LTI Mindtree
07.2022 - Current
- Plan and lead validation and qualification activities for clinical systems, ensuring compliance with regulatory requirements.
- Author CSV/CSA validation deliverable documents.
- Create a Functional Risk Assessment.
- Review and approve all validation deliverables, including the Validation Plan, Validation Summary Report, Execution Summary Report, UAT Plan, and UAT Report.
- Create a System Level Risk Assessment (SLRA) and IT Change Request for new, monitoring, and evaluation clinical studies.
- Develop and execute UAT plans and validation protocols for clinical studies.
- Quality check, review, and approve validation protocols for systems including eDiary, YPrime, IRT, Clario, Suvoda, eCOA, Myfood24, and Kaufman clinical systems.
- Develop and review the Validation Plan and Validation Summary Report for clinical operations systems to ensure adherence to regulatory requirements.
- Review the System Delivery Life Cycle (SDLC) deliverables, and provide constructive feedback to ensure compliance with SOPs and working procedures.
- Assist in creating SOPs and validation protocols.
- Validate change controls, OQ. PQ protocols using Agile methodology.
- Manage all validation deliverable activities by following SOPs.
- Tools used: Veeva Quality Docs, Valgenesis, ServiceNow, ALM, and DocuSign.
Senior Validation Engineer
ICON Plc
09.2019 - 07.2022
- Planned and led validation and qualification activities for the Fircrest Project ensuring compliance with regulatory requirements and ICON SDLC
- Authored CSV/CSA documents for internal and external audits
- Validated IQ servers, change controls, OQ protocols, Agile processes, and reviewed test cases/test suites for both manual and automated testing
- Created and reviewed key qualification and validation deliverables such as IQ Protocol/Report, System Test Protocol, Test Plan, Test Script Review Form, Test Scripts, Test Completion Report, OQ Test Phase Completion Memo, Requirements Traceability Matrix, and Validation Plan/Report
- Conducted meetings for Regulatory Impact Assessment (RIA), Validation Risk Assessment, and 21 CFR Part 11 Assessment under ICON SDLC, as well as Project Impact Assessment under Firecrest SDLC
- Reviewed SDLC deliverables, provided constructive feedback, and ensured adherence to SOPs/Working Procedures
- Utilized GAMP categories to perform validation activities and took responsibility for validation deliverables
- Represented Validation Services during sponsor audits and conducted external vendor audits
- Assisted in the creation of validation documentation as required under ICON and Firecrest SDLC
- Tools Used: ALM, Jira, Confluence, DocuSign, Veeva Quality Docs
Validation Engineer
AstraZeneca India Private Ltd
05.2016 - 09.2019
- Reviewed URS and FRS documents
- Created/reviewed key qualification or validation deliverables including IQ Protocol/Report, System Test Protocol, Test Plan, Test Script Review Form, Test Scripts, Test Completion Report, OQ Test Phase Completion Memo, and Requirements Traceability Matrix under the applicable SDLC
- Reviewed SDLC deliverables and provided constructive feedback to ensure adherence to SOPs/Working Procedures
- Executed OQ/PQ protocols, analyzed test results, and prepared OQ and PQ review forms based on GAMP categories
- Created and executed UAT scripts for a new Document Management System, covering workflows for document uploading, approvals, editing, version control, e-signatures, and withdrawal
- Reviewed Good Documentation Practices (GDP) for test scripts
- Created/reviewed Risk Impact Assessments and Validation Risk Assessments
- Performed periodic reviews to ensure maintenance of the validated state of systems
- Created/reviewed Validation Plans and Validation Summary Reports
- Managed change control activities and led a team responsible for end-to-end validation deliverable activities
- Tools Used: ALM, Jira, Confluence, DocuSign
Validation Engineer
Xybion India Private Ltd
01.2013 - 05.2016
- Created, reviewed, and executed IQ/OQ/PQ test cases
- Participated in dry runs and formal execution activities
- Conducted peer reviews (OQ) with team members
- Enhanced test cases to accommodate new application changes
- Participated in change controls, and reviewed and approved system changes
- Created validation plans and reports
- Reviewed Risk Impact Determination documents
- Evaluated SDLC deliverables to ensure compliance with governing procedures
- Tools Used: Census
Education
Bachelor of Engineering - Computer Science
Maharaja Institute of Technology
Coimbatore05-2010
Diploma - Computer Science
Government Women’s Polytechnic College
Coimbatore05-2007
Skills
- Computer System Validation/Computer Software Assurance
- Risk Impact Assessments (RIA)
- 21 CFR Part 11 assessment
- Documentation for Internal/External audits
- End-to-end validation deliverables
- Agile processes
- GxP
- Laboratory Information Management Systems (LIMS, Labmatrix, Labvantage, Labwise, Prisitma)
- Clinical Systems (ex: IRT, eDairy eCOA, YPrime, Clinical Database Management)
- Quality Management Systems (QMS)
- Learning Management Systems (LMS)
- Risk-based validation approaches
- GAMP 5 standards
- COTS products
- Leadership skills
- Change management
- Project management in regulated environments
Certification
- FDA Certified Professional – World of Compliance Overview
- Xybion Certified Professional – Good Documentation Practices
- FDA Certified Professional – Good Laboratory Practice
Timeline
Senior Quality Specialist
LTI Mindtree
07.2022 - Current
Senior Validation Engineer
ICON Plc
09.2019 - 07.2022
Validation Engineer
AstraZeneca India Private Ltd
05.2016 - 09.2019
Validation Engineer
Xybion India Private Ltd
01.2013 - 05.2016
Bachelor of Engineering - Computer Science
Maharaja Institute of Technology
Diploma - Computer Science
Government Women’s Polytechnic College
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