Chetan Kamini
Raleigh,NC
Summary
IT Computer Systems Validation Lead with 11+ years of experience in pharmaceuticals and biotech, successfully managing IT system validations to enhance compliance and quality management. Expertise in drafting and approving critical validation documents, ensuring alignment with 21 CFR Part 11 and GxP regulations, and driving project success through proactive risk assessments. Managed comprehensive validation and compliance efforts across multiple projects, guaranteeing alignment with GMP regulations and achieving flawless regulatory audit outcomes
Overview
11
11
years of professional experience
Work History
IT CSV Lead
Takeda Pharmaceuticals
Cambridge, MA
08.2019 - Current
- Designed and authored Validation Plans and Agile SDLC Plans (ASP) for GMSGQ implementations, prioritizing regulatory compliance throughout the process.
- Conducted thorough analysis and finalized GxP Risk Assessment document to ensure compliance and mitigate risks.
- Analyzed and validated User Requirements Specification (URS) documents, ensuring clarity and accuracy for development teams.
- Streamlined project documentation reviews, resulting in improved clarity and compliance in functional and technical specifications. Evaluated decommissioning plans and reports, contributing to successful project outcomes and risk mitigation. Facilitated thorough reviews of technical documents, ensuring alignment with project goals and regulatory requirements.
- Created detailed Functional Risk Profiles and test plans to ensure effective execution of GMSGQ implementations.
- Conducted thorough reviews and granted approval for IQ/OQ, SIT and UAT scripts, ensuring alignment with operational requirements.
- Oversaw approval process for deviations during testing phase, contributing to timely project delivery and maintaining quality assurance protocols.
- Developed Test Summary Reports, Requirements Traceability Matrices, Validation Summary Reports, and Agile Release Plans to ensure comprehensive project documentation and compliance.
- Conducted risk evaluations for AI models, aligning outputs with regulatory classifications to determine necessary validation levels.
- Identified and articulated AI/GenAI deliverables for GMSGQ projects to ensure comprehensive documentation was created, reviewed, and approved.
- Facilitated IT Infrastructure Qualification activities for Takeda’s EDB platform by authoring comprehensive Qualification Plan and Qualification Summary Report.
CSV Lead
Jubilant Pharma
Yardley, PA
01.2019 - 07.2019
- Formulated comprehensive Master Validation Plan for TrackWise-SAP integration, ensuring adherence to regulatory standards.
- Collaborated with stakeholders to complete User Requirements Specifications (URS) and Risk Assessment documents, enhancing project alignment and clarity.
- Crafted detailed Functional Specification wrapper (FS) and Installation Qualification Summary Report (IQSR) documents to facilitate effective validation process execution.
- Authored comprehensive Operational and Performance Qualification (OPQ) protocol, Summary Report (OPQSR), Requirements Traceability Matrix (RTM), and Validation Summary Report (VSR) to facilitate regulatory adherence.
IT CSV Lead
Catalent Pharma Solutions
Somerset, NJ
01.2018 - 12.2018
- Oversaw validation and compliance efforts for batch release processes to uphold product quality and regulatory standards.
- Designed and documented validation strategies tailored for both global initiatives and localized implementations.
- Developed comprehensive Functional Risk Assessment (FRA) document to identify potential vulnerabilities.
- Compiled Validation Summary Report (VSR) to encapsulate validation outcomes and facilitate regulatory submissions for global implementation.
- Evaluated and authorized global configuration qualification protocols and operational qualification processes.
- Managed deviations during protocol executions, mitigating risks and ensuring adherence to established protocols.
- Reviewed and sanctioned installation qualification protocols to ensure compliance with global MES system hot fix 3 and Swindon workstations.
- Evaluated and authorized global Design Specification (DS) document to guarantee adherence to regulatory standards.
- Authored comprehensive System Requirements Specification (SRS) document to guide project development.
- Compiled and organized global Requirements Traceability Matrix (RTM) to enhance visibility and tracking of project specifications.
- Developed and authored Catalent's specific Functional Specification (FS) document to ensure clarity and compliance.
- Evaluated and authorized GxP high-level risk assessment documentation.
Quality Analyst
Ortho Clinical Diagnostics
Raritan, NJ
05.2015 - 12.2017
- Monitored and validated adherence to quality standards and compliance regulations for GxP and non-GxP systems during separation from Johnson & Johnson.
- Evaluated and authorized validation documents, including User Requirements Specifications (URS), Functional Specifications (FS), and Configuration Specifications (CS).
- Designed detailed reports for data migration system testing and UAT, facilitating meticulous validation of system configurations.
- Authored detailed Requirements Traceability Matrix (RTM) to systematically document user requirements and testing results, guaranteeing all requirements received validation during testing.
- Conducted thorough assessments of testing processes and documentation, uncovering gaps and formulating actionable strategies to resolve discovered issues.
- Evaluated and refined system features to improve overall performance and align with user needs.
- Evaluated architecture design documents for each system to ensure compliance with project specifications.
- Executed comprehensive review and updates of test scripts within Rational tool.
- Documented findings and insights in Validation Summary Report for each individual system, enhancing clarity and understanding.
- Assisted in cutover activities by reviewing production readiness transactions and testing data verification details of objects. Supported production readiness by validating transactions and ensuring data verification accuracy.
- Developed comprehensive Compliance Plan and Compliance Analysis documents for individual systems.
- Assisted in internal PwC audit efforts and provided support to Ortho in responding to auditor questions.
- Facilitated effective change management by meticulously reviewing and authorizing change control forms.
Education
Master of Science - Industrial And Physical Pharmacy
Long Island University
Brooklyn, NY12-2014
Bachelor of Science - Pharmaceutical Sciences
Dr. M.G.R Medical Univeristy
India08-2011
Skills
- GxP (GMP, GCP, GLP)
- 21 CFR Part 11, 21 CFR Part 210/211, 21 CFR Part 820, EU Annex 11,
- Agile, V-Model and Waterfall methodologies AI/GenAI
- Test Protocol design, Requirement Analysis, Test Plan, IQ/OQ/PQ, User Acceptance Testing, Regression Testing, System Testing, Integration Testing MF-ALM, qTest, Rational
- MS Office Suite, SharePoint, Document Management Systems, Learning Management Systems, Jira, Confluence
Timeline
IT CSV Lead
Takeda Pharmaceuticals
08.2019 - Current
CSV Lead
Jubilant Pharma
01.2019 - 07.2019
IT CSV Lead
Catalent Pharma Solutions
01.2018 - 12.2018
Quality Analyst
Ortho Clinical Diagnostics
05.2015 - 12.2017
Master of Science - Industrial And Physical Pharmacy
Long Island University
Bachelor of Science - Pharmaceutical Sciences
Dr. M.G.R Medical Univeristy