Murali Nandurka

Murali Nandurka
201 885 8484

muraliidm11@gmail.com
PROFESSIONAL SUMMARY:
 Professional and technical experience in the Computer System validation for FDA regulated Life Sciences industry.
 Excellent experience in the implementation of SCADA, PLC, BMS, Documentum, QMS, Valgenesis, Veeva Clinical Vault
application.
 Excellent working knowledge and grasp of Data Integrity guidelines – MHRA and FDA’s GMP Data Integrity definitions and
guidelines including ALCOA framework – Attributable, Legible, Contemporaneous, Original and Accurate
 Hands-on experience working on assessing the Data Integrity health of computerized systems Manufacturing Plants and R & D
Sites using Data Integrity checklists.
 Extensive experience in Computer Systems Validation, Implementation of 21 CFR Part 11, Annex 11, MHRA and other regulatory
requirements.
 Extensive validating experience in FDA regulated environment with good understanding of cGxP (GMP, GDP, GCP and GLP).
 Technical and precise experience in Infrastructure Qualification and Data Center migration.
 Worked with a Data Center migration to Cloud (AWS).
 Well versed in validating Cloud based applications – Software as a Service (SaaS), Platform as a Service (PaaS) and Infrastructure
as a Service (IaaS).
 Experience developing and performing factory/site acceptance testing, validation, and decommissioning plans
 Experience creating, developing, and executing System Life Cycle (SLC) documentation for automated equipment/systems,
optical tooling instruments and computer systems, such as High-Level Risk Assessment (HLRA), Qualification Need Assessment
(QNA), 21 CFR Part 11 Assessment, SOP’s, Validation Master Plans (VMP), Installation Qualifications (IQ), Operational
Qualification (OQ), Performance Qualification (PQ), and Validation Summary Reports (VSR). Conducts risk assessments and
determine revalidation or qualification needs based on gap analysis.
 Developing, review and approval of User Requirements, Detailed Design, and Functional Specifications
 Conducting 21 CFR Part 11 assessments of software and computer systems Quality & Compliance skills.
 Assist to implementing continuous improvements to the Quality Systems required to execute and implement current good
manufacturing practices (cGMPs)
 Experience reviewing and evaluating System Life Cycle documentation, Computer Validation Protocols, Analytical Laboratories
Protocols, and their applicable SOP’s.
 Experience in approval of validations documentation associated to Manufacturing, Process, and Engineering related
Manufacturing Equipments/Systems, Optical Tooling Instruments, Computer/Computerized Systems, and Analytical
Laboratories Systems.
 Ensuring various departments’ acts in accordance with company policies and procedures, and their compliance with the
regulatory aspects, cGxP guidelines, FDA Code of Federal Regulations (CFR) rules, and ISO requirements, were applicable.
Engineering Project Management/General Skills
 Project Management and coordination of validation projects
 Technical writing and presentation experience
 Proficient with Microsoft Office (Work, Excel, PowerPoint, SharePoint, Teams, Outlook, Visio, Access).
 Strong ability to manage multiple projects, tasks, and goals with tight deadlines.
 Excellent planning, technical, problem solving and interpersonal skills.
PROFESSIONAL EXPERIENCE
Sanofi, NJ 11/2020 – Till Present

Sr. Validation Engineer
Responsibilities:
 Led end to end validation activities for SCADA, PLC, Veeva Clinical Vault, Documentum and TrackWise.
 Authored Engineering Documents (Functional, Configurational, Design) based on the vendor packages.
 Authored Pre IQ-Test Scripts to test the functionality in Simulated environment.
 Authored IQ Test cases to verify Configuration, Infrastructure, Graphics, Control Panel Drawings, Loop Checks, and I/O
Configuration.
 Authored OQ Test Cases to Verify Control Modules, Equipment Modules, Phases, Recipes, Graphics, Software Security,
Hardware Security.
 Authored Test scenarios for CDMS, CTMS and eTMF in Veeva Vault
 Leveraged Assessment tools like Archer to determine security and 21 CFR part 11 requirements for In-house and cloud based
applications.
Murali Nandurka
201 885 8484
 Coordinated with Quality in finalizing the Data Integrity requirements

 Analyzed data integrity requirements for IT Systems
 Performed Data Integrity Assessment for IT Systems
 Coordinated with Veeva Systems to finalize the Data Integrity assessment for Veeva Vault
 Support the Project Team with regards to aspects of project related risk, compliance and quality.
 Coordinate with the System Owner to develop Functional Requirements, User Requirements, Unit test scripts, UAT scripts,
validation plans, validation summary report, IQ/OQ/PQ.
 Defined Validation Strategy according to client procedures and policies
 Reviewed and approved URS, FRS, Risk assessment, Regulatory assessment,21 CFR part 11 assessments, GAP analysis document,
Test Deviation Report, Validation plans, Validation reports, IQ/OQ/PQ protocols, Change controls and Problem reports.
 Responsible for reviewing and approving all the validation deliverables
 Reviewed and approved FDS and TDS for custom objects (RICEWF objects)
 Prepared detailed compliance reports for Installation Qualification (IQ), Operational Qualification (OQ), as well as Performance
Qualification (PQ) protocols in agreement to FDA standards.
 Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan and
Change Control Summary Report.
 Implemented change controls, release management, version control and document control.
 Extensively experience in defect tracking, reviewing, analyzing and reporting test result using Test Director.
 Tracked the validation progress through validation assessment reports.
 Participated in compliance audits of systems, general assessments, risk assessments, 21 CFR Part 11 assessments.
 Reviewed and modified existing Standard Operating Procedures (SOP’s) for document management system, System
Administration, Change Control Procedures and Testing SOP’s.
Abbott, IL 12/2017 – 10/2020

Sr. Validation Specialist
Responsibilities:
 Performed End to End validation of SCADA, PLC and BMS System to automate the manufacturing line of different assembly lines.
 Reviewed and executed IQ/OQ Test cases to verify Configuration, Infrastructure, Graphics, Control Panel Drawings, Loop Checks,
and I/O Configuration and Control Modules, Equipment Modules, Phases, Recipes, Graphics, Software Security, Hardware
Security.
 Analyzed the validation impact of changes through risk assessment and helps in formulating the validation strategy for changes
to existing or new computer systems.
 Identified the root causes and resolved major incidents and coach others to approach problems systematically.
 Coordinated with third party Data Center service provider technicians, Internal Infrastructure Project Managers and Application
Team technical analysts to ensure Infrastructure Design and Configuration specifications are created per company’s
Infrastructure Qualification SOPs.
 Performed Data Integrity Assessment for the Data Integrity requirements
 Responsible for facilitating meetings with sites across the globe to assess the Data Integrity health of manufacturing plants and
R & D sites.
 Corrected and performed data integrity functions by reconciling data between source and target systems.
 Conducted routing Internal inspections of regulated systems (GCP) to assure validation procedures have been followed in
compliance with company, divisional and departmental policies and predicated rules.
 Represented Validation in Business Workshops and gathered requirements.
 Developed and maintained the following validation deliverables – Validation Plans, URS/FRS, Trace Matrix, IQ/OQ Protocols,
Infrastructure Risk Assessments, Infrastructure Change Controls, Regulatory Assessment, 21 CFR Part 11 Assessment.
Biomarin, Novato, CA 04/2014 – 11/2017

Validation Analyst
Responsibilities:
 Developed validation strategy for Empower and SAP projects
 Analyzed and approved the validation documentation.
 Assisted in the preparation of a validation plan and supported strategy.
 Conducted physical testing in compliance with local procedures.
 Conducted cleaning validation sampling in compliance with validation procedures.
 Created validation test scripts and procedures.
Murali Nandurka
201 885 8484
 Strong analysis, verification, planning, and project management.

 Performing gap analyses and risk assessments (GMP, GLP, GCP, 21 CFR Part 11, and HIPAA).
 Document requirements, traceability and risk analysis.
 Receive validation excel spreadsheet assignments with goals pertaining to validation/qualifications of equipment and software.
 Develop written validation/revalidation protocols including designing appropriate validation deliverables.
 Develop and review all deliverables including: test plan, functional requirements specification, user requirements specification,
validation plan, validation summary, traceability matrices, scenario maps to ensure design requirements are met.
 Conduct design qualification for relevant process equipment and SOPs.
 Develop and review validation requirements.
 Work with validation teams to support and monitor efforts.
 Perform execution of validation protocols and/or revalidation standard operating procedures (SOPs) and use data analysis skills
in assuring accurate interpretation of data.
 Develop written final report packages by analyzing results and preparing summaries of the data to support test and protocol
requirements.
BPL Plasma, Austin, TX 06/2012 – 03/2014

Validation Analyst
Project: CTMS, Lab Instruments
Responsibilities:
 Assigned responsibilities of identifying production issues and perform root causes analysis under the guidance of the senior
validation engineer
 Performed the tasks of developing process, preparing user manual, and providing support in product launch
 Handled responsibilities of reviewing manufacturing processes and developing standard protocols of equipment qualification
 Assigned the tasks of gathering customer requirements as well as performed measurement of new technologies
 Performed research on product characteristics and implemented new techniques to solve product validation issues
 Ensure that the validation process follows the standards and requirements of the company
 Develop manual and automated system-level verification tests.
 Develop and review test plan, traceability matrices, and scenario maps to ensure design Requirements are met.
 Develop and review functional requirements specifications.
 Conduct periodic qualification evaluations to ensure equipment is qualified.
 Develop validation protocols and associated summary reports.
 Manage requirements-to-verification traceability in ReqPro.
 Responsible to improve tools, techniques, and metrics around effective test verification approaches.
 Responsible and accountable for carrying out the requirements of the company's quality system
 Experience in product development from conception to release.
 ISO, FDA or other regulated industry training and/or experience.
EDUCATION: Masters, Information Assurance, Wilmington University

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Murali Nandurka

201 885 8484

Sanofi, NJ 11/2020 – Till Present

 Coordinated with Quality in finalizing the Data Integrity requirements

Abbott, IL 12/2017 – 10/2020

Biomarin, Novato, CA 04/2014 – 11/2017

 Strong analysis, verification, planning, and project management.

BPL Plasma, Austin, TX 06/2012 – 03/2014

EDUCATION: Masters, Information Assurance, Wilmington University

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