Quality Assurance Validation Engineer
Resume:
SHRUTI JHA
VALIDATION ENGINEER
CONTACT
**************@*****.***
SKILLS
Computer System Validation
** *** **** **, **** 809; part 820; part 830
210
Annex 11
GMP
GLP
GCP
GDP
SOP's
GAMP5
GAMP5 for Windows 7 and 10 upgrade.
GC/GC Headspace Sampler
Audit trails.
Authored and Executed Validation protocols (IQ, OQ, PQ)
HPLC
UAT
CAPA
FMEA(RRA/FRA)
Change Control Management
Deviation Management
Data Integrity (DI)
ISO 9001
ISO 13485
ISO 14971
ISO/TR 14969
RTM and Validation Summary Reports
Methodologies
Agile
Waterfall
V-model
Application
DocuSign
EDMS
LIMS
Compliance Wire
Veeva Vault apps
Mango
Tools
MS Access
MS Project
SharePoint
HP ALM
JIRA
FMEA (pFMEA, uFMEA, dFMEA, Hazard Analysis)
JProbe 7.0.3
WAS 6.1
IBM ARM
Thread Dump Analyzer
HTTP Watch
Technical Writing
Validation Plan (VP)
Master Validation Plan (MVP)
Functional-level risk assessments
Functional Requirement Specification (FRS)
User Requirement Specification(URS)
Requirement Traceability Matrix (RTM)
Validation Protocols
Validation Summary Report (VSR)
Database
Oracle (SQL, PL/SQL)
RAC DB
PROFESSIONAL SUMMARY
Accomplished Validation Consultant with a robust background leveraging expertise in Computer System Validation and 21 CFR Part 11, 809,820,830, Annex 1, Annex 11 to ensure regulatory compliance. Excelled in risk analysis, CAPA implementation, and validation protocol authorship. Experience working with large-scale ERP systems (including SAP) to validate data flows, ensuring compliance with quality standards. Skilled communicator, adept in aligning cross-functional teams with quality standards and system integrity.
EXPERIENCE
Validation Engineer
Millipore Sigma
May 2024-Present
Wrote, coordinated, and executed qualification protocols including IQ, OQ, PQ for process, equipment, facility, and utility.
Executed commissioning and qualification test functions in support of approved protocols.
Reviewed, summarized, and presented data in a Summary Report for management review and approval.
Maintained cGMP compliance in the laboratory.
Performed requalification, data integrity assessments and periodic performance reviews.
Validated equipment such as Refrigerators, Freezers, Ultra-Low Freezers, Plate washer, Plate reader, Ventana Benchmark Auto stainers, Incubators,CO2 Incubator, Label Printer, Slide Printer, Slide Scanner, Microtome,etc.
Acquired and demonstrated the ability to use site documentation systems such as: Quality Tracking System, Document management systems, Training, Maintenance management etc.
Reviewed and recommended the impact of change control requests.
Recommended required level of validation and propose plans to maintain systems in a compliant, validated state.
Reviewed process changes and validation in support of Annual Product reviews
Performed peer review for Standard Operating Procedures (SOP’s) for new equipment/processes, as well as update existing validation life cycle management SOPs.
Performed peer review of all validation documents.
Created validation master plans for new systems/processes.
Assisted with Cleaning Validation.
Involved in all aspects of the computer systems validation lifecycle, to comply with FDA 21 CFR Part 11, Part 809; Part 820; Part 830, Annex 1, Annex 11 GMP and GxP regulations.
Performed Periodic reviews for the label printers, Plate Readers, and Benchmark.
Followed regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance.
September 2020-January 2024
Validation consultant
Orchid Orthopedic Solutions, Bridgeport
Analyzed User Requirements Specifications and System Requirement Specifications (SRS)
Involved in complete validation life cycle to ensure systems compliance with 21 CFR part 11
Collaborated with cross functional team to performed Gap Analysis on legacy systems.
Performed risk analysis and CAPA remediation for identifying gaps with the team.
Generated a Remediation Plan for all the identified gaps for validation prospective.
Executed validation Protocols and prepared final reports for systems.
Collaborated with cross-functional teams to ensure SAP QM module was properly configured and validated for regulatory compliance.
Worked with SAP MM and PP modules to verify production and material management processes were aligned with regulatory requirements.
Analyzed scripts for testing the Audit Trail and Electronic Signature functionality.
Used Quality Center for error/defect reporting and communicating with the developers, product support team, and QA team members.
Prepared a detailed Test Summary Report for the implemented test scripts.
Carried out integration and system testing after application updates.
Executed OO and PQ protocols, resolved all deviations/discrepancies, and authored Validation Summary Reports
Reviewed and revised the Requirements Traceability Matrix to ensure that all the requirements are appropriately tested.
Authored Validation Summary Report and Test Summary Report detailing the successful completion of validation activities.
Authored, reviewed, and executed IQ, OQ and PQ protocols for two modules of LIMS application: Lot Management and Reports, Labvantage Biobanking system.
Involved in all aspects of the computer systems validation lifecycle, to comply with FDA 21 CFR Part 11, Annex 11 and GxP regulations.
Worked in a team to review and approve the Functional Requirement Specifications (FRS)
Involved in Requirement Risk Assessment (RRA) and come up with testing strategies.
Reviewed, Recorded, and managed IQ, OP, PQ, and other validation documents using document management system (Veeva Vault)
Followed SOPs for data backup procedures.
Responsible for documenting Test Plans that contain Test Scripts, test data and expected results for user-acceptance testing (UAT)
Drafted Requirement Traceability Matrix (RTM) to track and ensure all the requirements are tested.
Developed and analyzed test scripts to check all functionalities of the system have been covered within compliance of 21 CFR Part 11
Created Validation Summary Report (VSR) to summarize overall validation activities.
August 2018 - August 2020
Validation Engineer
Terumo Cardiovascular, MI
Worked with Validation Manager in defining the boundaries of validation activities in Planning.
Participated in a multi-phase project for planning and execution of Computer System Validation of the GMP functions of Oracle ERP (Supply Chain Management which includes Order Management, Purchasing, etc.) Reviewed and provided feedback on existing/new URS, Functional Spec, Design Spec, Test Scripts, and User Manual for computerized systems, digital products, and software applications.
Developed, reviewed, and executed the system-related IQ, OQ, and PQ
Involved in the creation and proper execution of Performance Qualification Protocols/ User Acceptance Testing of Sales Orders in Oracle Order Management
Verified Process Mapping to author the PQ protocol.
Provided feedback and review on test scripts.
Reviewed, coordinated, and maintained Change tickets.
Performed Periodic review for equipment’s
Reviewed system SOPs from a Validation perspective to ensure that they can be used effectively in maintaining the system.
Wrote and executed test scripts based on the test plan and per Good Documentation Practices (GDP)
Authored Requirement Traceability Matrices (RTM) by mapping system design documentation (Requirements, Functional Specs, Design Specs) to test scripts.
Participated in preparation of Validation Plan and reviewed the business and functional requirements.
Drafted, reviewed, and executed Operational Qualification (OQ) Protocols for Veeva Quality Suite in compliance with FDA standards.
Maintained validation package based on the requirements to meet the GxP and FDA 21 CFR Part 11, 211 compliance strategies.
Hands on experience with validating HPLC to ensure that the system, instruments, and procedures meet predefined criteria and specifications.
Reviewed several CSV deliverables: SOPs, IQ, OQ, PQ, RTM, VSR
Worked on Change Management using Track Wise application.
Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.
Maintained Requirement Traceability Matrix (RTM) to track User and Functional requirements.
Created, assigned, and managed project using SharePoint.
Executed Instron with test method.
Managed training program of validation personnel using Compliance Wire
Participated in preparation of Validation Summary Report (VSR).
July 2016 - July 2018
Jr. Validation Engineer
Neo Genomics, Irvine
Responsible for authoring/updating/reviewing/executing the OQ and PQ test scripts for the custom ERP application.
Responsible for the OQ formal execution and raising any defects in HP ALM
Responsible for gathering the requirements from the business and making sure that all the requirements are covered in the test scripts.
Responsible for authoring and updating the Trace Matrix
Responsible for authoring and dry run of the System and UAT scripts
Responsible for authoring and executing the OQs and PQs for Master Control v11
Assisted the Validation Lead in authoring the Validation deliverables for the implementation of the application.
Authored the test Plan for the Data Migration
Updated the Data Migration scripts to include the new requirements.
Analyzed User Requirements Specifications and System Requirement Specifications (SRS)
Involved in complete validation life cycle to ensure systems compliance with 21 CFR part 11
Performed Gap Analysis on legacy systems to assess the application's validation status, including Part 11 compliance.
Performed risk analysis and CAPA remediation for identifying gaps.
Gathered additional business requirements for the application and developed functional requirements specifications.
Generated a Remediation Plan for all the identified gaps.
Executed validation Protocols and prepared final reports for systems.
Analyzed scripts for testing the Audit Trail and Electronic Signature functionality.
Used Quality Center for error/defect reporting and communicating with the developers, product support team, and QA team members.
Prepared a detailed Test Summary Report for the implemented test scripts
Carried out integration and system testing after application updates
Executed OO and PQ protocols, resolved all deviations/discrepancies, and authored Validation Summary Reports
Reviewed and revised the Requirements Traceability Matrix to ensure that all the requirements are appropriately tested
Authored Validation Summary Report and Test Summary Report detailing the successful completion of validation activities.
EDUCATION QUALIFICATION
Bachelor’s in computer application.
.
Contact this candidate