PRATIMA CHOUDHARY
Senior Validation Expert | Driving Excellence In Validation And Regulatory Adherence
Mississauga
Summary
Motivated and Result driven Validation professional with a career spent in establishing validation strategies for GxP computerized systems, including system documentation review, development of validation plans/reports, and ensuring compliance with regulatory standards (CFR 21 FDA Part 11, Annex 11, EU GMP Annex 11) in Pharmaceutical & Clinical Research Organization(GCP/GLP), Healthcare Logistics (GMP) & Drug discovery (GCP/GMP). Proficient in conducting deviation investigations, root cause analysis, and defining corrective and preventive actions. Possess strong leadership quality, multitasking, problem solving and strong communication skills both oral and written. Adept at leading audit and inspection preparations, maintaining system validation states, and performing periodic reviews. Expertise in Cloud-based platforms (SaaS), Artificial Intelligence, and tools such as Veeva, JIRA, and RETINA. Strong background in Agile methodologies (SAFe, Scrum) and skilled in risk assessment, leadership, and cross-functional collaboration within diverse teams. Committed to continuous improvement and knowledge sharing in validation processes.
Overview
19
19
years of professional experience
6
6
years of post-secondary education
2
2
Languages
Work History
Validation Technical Lead
Billennium
Mississauga, Ontario
02.2022 - Current
- Develop and implement validation strategies for GxP computerized systems, ensuring compliance with FDA regulations (CFR 21 Part 11, Annex 11) and EU GMP Annex 1.
- Implemented continuous integration and deployment strategies for faster release cycles and improved application reliability.
- Review and approve system documentation, validation plans, test plans, and reports in accordance with internal SOPs and regulatory requirements.
- Evaluated and recommended new tools and technologies that resulted in increased development efficiency and up-to-date technical skillsets within the team.
- Lead testing activities, providing consultancy on deviations, root cause analysis, and corrective actions.
- Prepare systems for audits and inspections, ensuring all documentation is audit-ready and compliant with industry standards.
- Maintain validated system state and IT controls, conducting periodic reviews and implementing continuous improvement initiatives.
- Collaborate with cross-functional teams to drive validation excellence and share knowledge on best practices.
- Proficient in Cloud-based platforms (SaaS), AI, and EDMS tools (Veeva, Valgenesis), ALM Tools (JIRA, HP ALM, RETINA).
- Expertise in Agile methodologies (SAFe, Scrum), risk assessment, and data security.
- Facilitated knowledge sharing sessions, strengthening team expertise and fostering collaborative work environment.
- Proved successful working within tight deadlines and a fast-paced environment.
- Strong leadership, conflict management, and cross-functional collaboration skills, driving team success in dynamic environments.
Systems Validation Manager
Accuristix Health Care & Nova Pack
Vaughan, Ontario
08.2019 - 01.2022
- Manage Master Validation Plan related to systems (SaaS Cloud based systems, Warehouse Management, Temperature Monitoring System, Order Management, Document Management System) & devices (RF Guns & Tablets) for Accuristix & Nova Pack distribution locations
- Responsible for validation of Quality Management System and performing validation assessments on the updates
- Maintain system governance for Accuristix & Nova Pack and develop SOPs related to systems, governance & data integrity
- Manage program for assessment of systems which impacts GMP and follow risk based compliance
- Maintain and approve systems governance policies/SOPs
- Ensure GMP systems meet Health Canada data integrity requirements
- Assess any cloud computing system used by Accuristix & Nova Pack for adherence/validation to Health Canada data integrity requirements
- Project leader in coordinating validation projects between various teams
- Manage the Change Control system by completing validation assessment and identifying validation requirements for Accuristix & Nova Pack projects
Sr Clinical Systems Specialist
Syneos Health (Previously INC Research)
Toronto, Ontario
02.2018 - 08.2019
- Provide support to validation team with other validation activities related to equipment, facilities, temperature, etc
- Responsible for the development and maintenance of validation related SOPs
- Train end users and IT staff on system validation processes and procedures
- Review, sign-off and file QA records according to SOPs, Health Canada regulations and 21 CFR Part 11
- Responsible to provide regular updates to the executive teams on the status of the company's compliance to industry and regulatory requirements
- Provide support with regulatory & Client audits for validation related inquiries
- Subject matter expert for specialized computerized systems that elicits, analyzes, designs, tests, and validating specialized software and solutions having GxP Impact
- Validate computerized systems (perform analysis and develop/review validation documentation), maintain the validated state of systems, ensure compliance with FDA 21 CFR Part 11 and GAMP5, and adherence to the System Development Life Cycle Methodology
- Manage User Acceptance Testing process including planning of timelines and resources, development of all relevant documentation (user requirement specifications, test scripts, Summary Reports etc.), execution of test plans, coordinating of sign off documents, and configure test and production environments, etc
- Manage system change control process, perform analysis of changes and issues, implement application changes, and ensure that the issues and solutions are understood
- Lead requirement gathering, analysis and documentation of business needs
- Provide end user support for application and computerized systems with technical troubleshooting and issue resolution
- Training and consulting to the end users
- SOP development & Review
Clinical System Validation Specialist
INC Research
Toronto, Ontario
02.2016 - 02.2018
- Develop and maintain system documentation for all phases of Software validation cycle such as Planning, Analysis, Design, Implementation & Maintenance
- Develop and execute validation master plans, IQ (Installation Qualification)/ OQ (Operational Qualification)/ PQ (Performance Qualification) plans and reports
- Perform Risk Assessment for systems and Periodic Reviews
- Assess and implement system related changes and maintain system compliance to industry regulations
- Develop processes, policies, procedures, and guidelines for the usage and validation of the computerized systems; develop templates and maintain a repository of validation documents; ensure adherence to corporate policies, procedures, and processes
Computer System Validation Associate II
Pharma Medica Research Inc
Mississauga, Ontario
02.2014 - 01.2016
- Validate new and existing computerized systems including LDMS applications; COTS (Commercial Off the shelf) and Temperature Monitoring software for compliance with company Standard Operating Procedures, validation program and related regulatory requirements
- Develop validation documentation (User Requirement Specification (URS), Functional Requirement Specification (FRS), Risk/GxP/ER/ES Assessment, validation plan, Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Traceability Matrix (TM) and reports) and execution of test scripts
- Implementation and maintenance of FDA 21 CFR Part 11 and related validation and regulatory requirement activities
- Manage change control process, analyze changes and perform risk assessment
- Perform vendor assessments and to provide internal/external audit support and training
- Perform periodic reviews, re-validation and decommissioning procedures
- Developed Standard Operating Procedures for computer system validation, policies and processes
Computer System Validation Associate I
Pharma Medica Research Inc.
Mississauga, Ontario
02.2012 - 02.2014
- Validate new and existing computerized systems to maintain the compliant state
- Develop and maintain the validation documentation (validation plan, DQ, IQ, OQ, PQ, and reports)
- Analyze and develop user requirements, test cases and traceability matrix
- Perform functional, regression and performance testing
- Implementation and maintenance of FDA 21 CFR Part 11 and related validation and regulatory requirement activities
- Manage change control and change management activities
Validation Engineer
Jubilant Biosys Ltd
Bangalore
01.2006 - 01.2010
- Assisted the information technology team with various compliance related requirements and SDLC lifecycle
- Requirement gathering and preparation of FRS, URS and design documents
- Preparing validation documents (Validation Plan, IQ, OQ, PQ, VR, Risk Assessment, and Traceability Matrix)
- Reviewed requirements specifications, Data migration plans, technical design documents
- Reviewed pre and post executed user acceptance test cases, system test cases, unit test cases, and infrastructure and application IQ/OQ test cases
- Provide training (internal and client) and software demonstrations at client locations (USA, UK and Japan)
- Analysis of statistical data related to high throughput screening and gene expressions
Education
Post Graduate Diploma - Information Technology
Symbiosis Center of Distance Learning
Pune, MH 09.2007 - 03.2009
Post Graduate Diploma - Bioinformatics
IBAB
Bengaluru, KA 11.2005 - 05.2007
Master of Science -
Seedling Academy of Design Technology And Management
Jaipur, RJ 08.2002 - 05.2005
Skills
Technical Skills
- Computerized System Validation (CSV)
- GxP Compliance (Good Manufacturing Practice, Good Clinical Practice, etc)
- FDA Regulations (CFR 21 Part 11, Annex 11)
EU GMP Annex 11 compliance
- Risk Assessment (System and Data Risk)
- Cloud-based Platforms (SaaS)
- Validation Documentation (Validation Plans, Reports, Test Plans)
- Deviation Investigation & Root Cause Analysis
- Audit and Inspection Preparation & Execution
- Application Lifecycle Management (ALM) Tools (eg, JIRA, RETINA)
- Agile Methodologies (SAFe, Scrum)
- Continuous Improvement Practices
- System Maintenance and Configuration Management
- Data Integrity and Security
Soft Skills
- Leadership and Team Management
- Cross-functional Collaboration
- Communication and Reporting
- Consultancy and Training
- Conflict Management
- Problem Solving and Analytical Thinking
- Attention to Detail
- Adaptability to Regulatory Changes
Timeline
Validation Technical Lead
Billennium
02.2022 - Current
Systems Validation Manager
Accuristix Health Care & Nova Pack
08.2019 - 01.2022
Sr Clinical Systems Specialist
Syneos Health (Previously INC Research)
02.2018 - 08.2019
Clinical System Validation Specialist
INC Research
02.2016 - 02.2018
Computer System Validation Associate II
Pharma Medica Research Inc
02.2014 - 01.2016
Computer System Validation Associate I
Pharma Medica Research Inc.
02.2012 - 02.2014
Post Graduate Diploma - Information Technology
Symbiosis Center of Distance Learning
09.2007 - 03.2009
Validation Engineer
Jubilant Biosys Ltd
01.2006 - 01.2010
Post Graduate Diploma - Bioinformatics
IBAB
11.2005 - 05.2007
Master of Science -
Seedling Academy of Design Technology And Management
08.2002 - 05.2005
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