Chemical Engineering Medical Device
Resume:
Rakesh Guni
adhjr5@r.postjobfree.com
Professional Summary:
•Validation professional with 6+ years of experience in Validation/QA/QC and analysis and Testing of process and applications in the Pharmaceutical Industry
•Experienced in developing and enhancing the Standard Operating Procedures (SOPs), Work Instructions worked with Quality closely assisting in the preparation of Gxp Quality system related training, review changes, and identifying gaps in existing Quality systems.
•Extensive knowledge and experience in validating computer systems following the Software Development Life Cycle (SDLC) as per FDA regulations and cGXP (GLP/GCP/GMP) guidelines.
•Data Integrity on the CSV audits per the ALCOA© thumb rules.
•Familiar with FDA regulations such as Title 21 CFR Part 11, Annex 11, 21 CFR Part 210, 21 CFR Part 211, and 21 CFR Part 820
•Experienced in using Documentum, SharePoint, Track Wise, HP Quality Center, Adverse Event Reporting System (AERS).
•Experienced in documenting User Requirements Specifications (URS), Functional Specifications (FS) and Design Specifications (DS) documents, Business Requirements, Installation Plan, System & UAT Test Scripts, deliverables for change control
•Experience in documenting Design Review (DR) and Qualification Protocol (QP), Technical Writing. Excellent experience as a Validation Specialist and in-depth involvement in writing test scripts for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ).
•Identifying and implementing quality system improvements.
Technical Skills:
Methodologies: Agile, Waterfall
Software: MS Suite, SharePoint, e-room, AERS, Track Wise, Doccumentum, eTMF, Argus Safety, R, R-studio.
Tools: Quality Center, Documentum, Track wise, HPALM, ServiceNow, JIRA, QDoccs
Regulations: FDA 21CFR-Part 211, GLP (21CFR Part 58, QSR (21CFR Part 820), ERES (21CFR - Part 11, GAMP4/5, SOX, FDA LIMS, AERS, Audit Trails.
PROFESSIONAL EXPERIENCE
Vertex Cell and Gene Therapy, Providence, RI Aug 2020-Current
CSV Lead -Medical Device Manufacturing
Qualifying the computer systems used in the manufacturing of the medical device in the pre-clinical research.
Validating the Automated Equipment with the help of Equipment Qualification (Fusion Robots, Frame attached robots, Laser-Driller/Chiller) to establish the grounds of validated state for further usage.
Developing the Validation Master Plan, Test Plan, System Requirement Specifications document, RTM, Summary report for the facility's computer systems and controllers.
Authoring the IQ/OQ protocols and overseeing the process of approvals and execution of the test protocols.
Biogen, Cambridge, MA May 2019 – Jun 2020
Validation Lead -MSPT 2.1-Medical Device-IPACS (Medical Imaging), GRID, HPALM
Responsible for conducting walkthrough sessions with SME's to discuss and finalize the functional requirements for the system
Reviewed/Approved validation documents URS, FRS, UAT, Validation plan/report, and RTM
Medical Device Testing for MSPT 2.1 Release.
Designing, Dry run, and execution of the test scripts for MSPT 2.1 testing across multiple languages to ensure MSPT 2.1 is implemented globally for the patients with MS.
Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and Gxp FDA Compliance Regulations.
Adhere to departmental and company-wide SOPs, policies, and procedures for software quality assurance directly contributing to quality deliverables
As part of the Validation plan, loading test cases into Test Lab on HPALM and routing the same for the DDQ review, followed by formal Testing, and mapping the requirements by creating an RTM.
Change management and coordination of assigned projects.
Designing the UAT scripts and providing support through the execution of the UAT's.
Driving the weekly Defect Triage meeting.
Working with the On-site/ Off-shore team.
Vertex Pharmaceuticals, Boston, MA Sep 2018 – May 2019
Validation Consultant-Track Wise, e-TMF, VDI, Argus Safety & ARIM
Reviewed/approved validation documents URS, FRS, UAT, Validation plan/report, and RTM
Designed and developed the Requirements Traceability Matrix (RTM) to trace requirements
Involved in developing Test Plans and Summary Reports for the Track wise implementation, which covered customization, validation of the workflows Audit/GMP/Commercial Class 1,2/3, Event Investigation and the child, aren't workflow behaviors.
Responsible for generating and reviewing CSV deliverables in compliance with 21CFR Part 11 and Gxp FDA Compliance Regulations.
Service-Now, JIRA platforms to work with the flow of transportation of changes between different systems.
Design test scripts for Argus Safety for negative/optimistic testing scenarios, modification/creation of reporting rules as requested by the business, tracking through different workflows of Adverse Event (right from creation of the event to the locked state).
Customization of Oracle Argus generated reports(E2B-R2) profiles, case forms, export logic, what fields need to be pulled into the database.
Successfully reviewed validation deliverables like Validation Plan, User Requirement document
Customizing the reporting rules for them to schedule/trigger a report under a specific set of conditions.
Developed test scripts for testing the functionality of Track Wise, eTMF, and Argus Safety.
Responsible for ensuring effective CSV deliverables for Veeva-Vault e-TMF & Track Wise implementation
Lupin Pharmaceuticals, Somerset, NJ Oct 2017 – August 2018
Validation Analyst- Spreadsheet, LIMS, Lab-Equipment
Reviewed Validation Master Plan (VMP) for validating analytical laboratory equipment's and LIMS
Involved gathering of User and System Requirements (URS and SRS) and reviewed OQ and PQ protocols
Developed and executed CSV life cycle requirements for systems including MES Solutions, commercially off-the-shelf software (COTS), and web applications
Responsible for conducting walkthrough sessions with SME's to discuss and finalize the functional requirements for the system
Created templates for test method validation protocol, method validation report, standard test method and Prepared documents for Test cases
Reviewed and updated Standard Operating Procedures (SOPs) and User Manuals for the equipment's and related software to ensure they meet FDA requirements
Reviewed/approved validation documents URS, FRS, UAT, Validation plan/report, and RTM
Developed test strategy to implement system changes requested by the business users using the Change Control process
Involved with writing test scripts and modifying the existing scripts for functional enhancement of the application
Performed GUI and Functional Testing of the LIMS screens using manual Testing
Designed and developed the Requirements Traceability Matrix (RTM) to trace requirements
Involved in performing Gap Analysis and preparing the Remediation plan
Hosted Interviews and selection process for appending new members.
Authored SOPs and WIs to validate spreadsheet systems for assay related calculations and acceptance criterion
Dr. Reddy's Laboratories, Hyderabad, India May 2013 – Jun 2015
Validation Specialist/Test Analyst – Track wise & SharePoint
•Monitored the Testing conducted by the QA dept. and documented the Validation Summary Reports. The project at Medimmune mainly involved working on Regulatory applications.
•I was involved in coordinating the approval of IT for Insight Publisher Upgrade through authorized Request for Change- RFC.
•Coordinated with Regulatory Operations to open a new Validated System Change Request in Track Wise to document the implementation of Insight Publisher Upgrade.
•Performed the change request process and completed the GXP analysis/ assessment and the 21 CFR Part 11 assessment.
•Successfully reviewed validation deliverables like Validation Plan, User Requirement Specification, Functional requirement Specification, System Design Specification document
•Drafted the Installation Qualification Protocol (IQP) as per release notes for the implementation of insight Patch.
• Performed periodic review of software/system, Part 11/ ERES System Specific Compliance assessments, and prepared formal reports.
•Involved in review, update, and pre-approval of IQP and OQP by uploading the documents in Aegis EDMS concerning System Owner, Validation, Information Technology, and Quality Assurance
•Involved in the post-execution documentation (as per GDP) of executed IQP and OQP and coordinated with System Owner, Validation, Information Technology, and Quality Assurance for post-approval.
Novartis, Mumbai, India Jul 2012- Apr 2013
Validation Engineer-HPQC & Track wise
•Managed project records in Track wise QMS (Incident reports, change controls)
•Developed applicable test cases for the integration test, system test, and acceptance test defects are tracked while processing Testing and reported using HP QUALITY CENTER and paper-based manual Testing.
•Logged and tracked compliance issues and incidents using Track wise
•Developed test scripts for testing the functionality of Track wise
•Performed the GAP analysis and Remediation Plans were developed for components that were not full and mostly compliant
•Tracked defects while testing and reported using HP QUALITY CENTER and manual Testing
•Involved in all phases of the validation lifecycle to comply with FDA regulations and GAMP assessment.
•Responsible for ensuring effective CSV deliverables for Track wise implementation
•Good understanding of the FDA submission process, including how the data must be aggregated and presented to the FDA
•Developed and executed IQ, OQ, and PQ protocols for product, processes, and equipment within the facility
Education
Executive Master's Information Technology, University of Cumberlands, KY
Master's in Chemical Engineering, Lamar University, TX
Bachelor's in Chemical Engineering, Birla Institute of Technology and Sciences, India
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