Susmitha Kancharla

405-437-5612
susmithak.tr@gmail.com

PROFESSIONAL SUMMARY:

 Expertise in Computer System Validation (CSV), Analytical Lab Instrument Validation, Technical Writing, Validation Testing and
with strict adherence to GAMP & cGMP regulations
 Experience in validation analytical Lab Instruments – Karl Fisher Titrators, Dissolution, Fluorescence Spectrophotometers, Glove
Testers, ECHO, HPLC, GC, FTIR, DSC, Plate Readers, PH Meters, Plate Readers, Balances, Incubators, Microscopes, Autoclaves,
Distillation Machines, Infra-Red Spectroscopy, PCR Machines, TOC Analyzers, Autoclaves, Water Purifiers, Air samplers etc.
 Experience validating Laboratory Information Management System (LIMS), ELN, labX, Veeva Vault, SAP System, TrackWise, Lab
Interfaces with ERP systems, Electronic Data Management Systems and Veeva in accordance with GxP regulations.
 Experience leading the validation of data migration from legacy systems to multiple enterprise systems.
 Good expertise in developing the following validation deliverables – Risk Assessments, Regulatory Assessments, 21 CFR Part 11
Assessments, Gap Analysis documents, Validation Plans, Qualification Protocols, Validation reports, IQ/OQ/PQ test scripts,
Deviation/Incident Reports, Change Controls and Problem Reports.
 Expert in managing tests and defects.
 Experience in providing training to business users on Good Documentation and Test Execution Practices.
 Developed functionality Test Scripts to test the system functionality based on approved system requirements.
 Excellent knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC).
 Involved in Change Control and developed Change Notification Form (CNF).
 Extensive experience in performing 21 CFR Part 11 Gap Analysis, Risk Analysis and developing Remediation Plans.
 Experience in developing Test Plan, Test case Specification and Test Release Reports for all phases of testing i.e. unit testing,
Integration testing IQ, OQ, PQ and UAT Testing.
 Experience in executing software validation protocols (installation and operational qualifications.)
 Excellent knowledge of 21 CFR Part 11, GLP, cGMP and GAMP guidelines.
 Demonstrated capabilities to quickly gain a detailed understanding of a process to optimize efficiencies, reduce cost, and
improve quality.
 Thorough knowledge on Data Integrity Concepts, ALCOA Principles.
 Excellent experience in AQL and ANSI sampling techniques.

PROFESSIONAL EXPERIENCE

Merck, PA Mar 2018 – Till Present

Sr. Validation Engineer
Applications: LIMS, ELN, LabX, Veeva, EtQ (Reliance), SAP and Lab Instruments
 Developed testing strategies and rationale for LIMS, LabX, ELN, Veeva, SAP and multiple add on systems.
 Reviewed and updated end-to-end validation documentation for LIMS, LabX, ELN, Veeva, EtQ (Reliance), SAP and ServiceNow to
ensure compliance with company policies and procedures.
 Monitored the development of interfaces between multiple systems LIMS, LabX, ELN, Veeva and SAP.
 Worked with cross functional teams including Business process owner, Quality Assurance, Regulatory, system owners for
implementing ELN, Veeva and LIMS projects.
 Developed Gap Analysis and provided mitigation strategies for LIMS implementation.
 Implemented ELN and LIMS modules (Raw Material, Manufacturing Lots, Stability and Environmental Monitoring) in a Phased /
Release approach and in parallel with interfacing to Equipment and Manufacturing Execution System.
 Developed URS, FRS, DS and other validation documentation for LIMS, LabX, ELN, Veeva and SAP.
 Developed SOPs and work instructions.
 Identified process improvement areas and conducted research to determine the best course of action.
 Developed data collection systems and other strategies that optimize statistical efficiency and data quality.
 Acquired and abstracted primary or secondary data from existing internal or external data sources.
 Followed GDP to record all validation activities performed and data generated.
 Participated in safety meetings, reports all safety issues, concerns and incidents.
 Worked with cross functional teams in moving the transports from one environment to other environments.
 Authored requirement specifications, data migration plan, IQ, OQ, PQ protocols, scripts and qualification reports, validation
report etc. for new equipment and software, enhancements, maintenance releases, upgrades and periodic reviews.
 Supported CSV efforts and participated in coordinating work, reporting status, resolving issues, and addressing change control
requests as they apply.
 Followed SDLC Methodologies and industry standard practices to Validate Computer Systems.

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 Gathered and documented User Requirements Specifications (URS) for various systems.
 Gathered, analyzed and created Functional Requirements Specifications (FRS).
 Developed and maintained the Requirements Traceability Matrix (RTM) in support of Validation.
 Performed Regulatory Assessment and Risk Assessment for the Computer Systems.
 Performed GAP analysis, developed Remediation plans.

West- Ward Pharmaceuticals, NJ Feb 2017– Mar 2018

Validation Engineer
Applications: Lab Instruments, Sample Manager LIMS, SAP and Veeva
 Participated in Business Workshops and understood user requirements and mapped them to the vendor provided Functional
requirement specifications.
 Defined validation approach for Sample Manager LIMS, SAP and Veeva applications.
 Developed current process flow diagrams and analyzed the business requirements.
 Prepared Business Process flows and had workshops, meetings with various departments to finalize the requirements.
 Analyzed site-specific requirements and updated global template documents for SampleManager, Veeva and SAP.
 Involved in Preparing complete set of validation deliverables from Validation Plan to Validation Summary Report.
 Prepared User Requirements Specification document as per the business need.
 Developed Standard Operating Procedures (SOPs) to operate/ maintain the system in Production.
 Wrote/Updated UAT test scripts and SQL queries.
 Monitored the execution of UAT test cases and documented the test results as per established guidelines.
 Developed Requirements Traceability Matrix (RTM) to keep track of relationship between Requirements and Test Scripts.
 Involved in Sample Manager LIMS, SAP and Veeva Change management process with respect to business process changes along
with time stamps and approval processes.
 Supported business in all GxP regulations, compliance with internal and external procedures, and all aspects of safe, reliable,
and consistent operation of the computerized system.
 Ensured system compliance to defined requirements, QMS, and system specific procedures.

ConvaTec, NJ Jul 2014 - Jan 2017

Validation Analyst
Applications: Lab Instruments, LIMS, Veeva and Data Management
 Performed Quality Risk management for various equipment.
 Provided validation support for areas of analytical Method development and Method validations by using HPLC, Dissolution,
Related substances and Assay, UOD by HPLC, Dissolution by HPLC, UV and GC.
 Led the development and validation of cost-effective analytical methods with shorter run times for Related Substances, Assay
Methods by using modern analytical techniques.
 Coordinated with vendors and suppliers on different technical and non-technical issues related to Products, Laboratory
requirements etc.
 Documented and reviewed SOPs’ Validation Protocols’ and implementation of Quality systems as per the cGMP and GLP
requirements.
 Actively participated in Audits conducted by different regulatory authorities including MHRA, USFDA etc.
 Well versed with Validation Practices including Equipment, Facility, Area Qualifications, and Cleaning Validation.
 Developed Decommissioning Activities for various lab instrumentation.
 Documented Sampling Points during the Installation Qualifications.
 Involved in developing Validation Plan, User and Functional Requirement Specifications, Summary Reports
 Reviewed Process flows, Requirements Documents, Configuration documents and Design Specifications.
 Partnered with Quality Assurance personnel to review and approve validation deliverables.
 Involved in IQ, OQ, PQ test script preparation and test executions including deviations if any.
 Worked with CAPA team to root cause of issues and preparation of deviation reports.
 Developed/Maintained the Requirements Traceability Matrix (RTM).
 Maintained Training Logs and Incident/ Test Case Assignment logs.

Education: Masters, Computer Science, University of Central Oklahoma, CA

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