Quality Assurance Data Migration
Resume:
Archita Gupta
Senior Validation Specialist
https://www.linkedin.com/in/archita-gupta-862651226/
Expertise:
Experienced in pharmaceutical industry as Validation Analyst and Compliance expert for medical devices and pharmaceutical equipment.
Profound knowledge of Quality System Regulations for medical devices and pharmaceuticals such as, 21CFR Part 11, 21, 210,211, 820; cGxP (GMP, GCP, GDP and GLP).
Proficient in meeting the 21 CFR Part 11 and EU ANNEX 11 requirements.
Excellent understanding of the Software Development Lifecycle (SDLC) with experience in various phases using V- Model and QA Methodologies.
Worked as an interface between technical and business environments for gathering and conveying User Requirements Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications.
Experienced in preparation of validation plan (VP) and review all validation deliverables before sign- off.
Extensive experience building test cases, test procedures and test reports.
Proficiency in preparation and execution of IQ, OQ, PQ, Validation Summary Reports and Requirement Traceability Matrix (RTM).
Well Versed in Quality Control tools and Testing for maintaining quality of the Pharmaceutical Products.
Experience in validation of Laboratory Equipment- HPLC, GC, Autoclave, Incubators, Clean rooms, Ovens.
Proficiency in validating, auditing and preparing SOPs for Pharmaceuticals and medical devices as per FDA regulations and providing corresponding user training.
Well experienced in writing technical documents such as Risk Assessment, Work Instruction (WI) and Failure Mode Effect Analysis (FMEA)
Reviewed new SOP’S (Standard operating procedures) and modified existing SOP’s and reviewed Work Instructions for various functionalities of the system.
Well Versed in Generating SOP’s and followed GMP Guidelines for ensuring the quality of the pharmaceutical products.
Proficiency in Data Migration, CAPA, Gap Analysis and Remediation Plans to ensure compliance.
Well versed with the use of Adverse Event Reporting System (AERS) in monitoring adverse effects and medication errors associated with therapeutic products.
Proven analytical and leadership skills as well as good in communication and interpersonal skills.
Education:
Master of Science in Chemistry - Chhatrapati Shahu Ji Maharaj University, Kanpur.
Knowledge Base:
Kneat Validation
Procore
Service now
ChemDraw
Cleaning Validation
Commissioning and Qualification
Technical Skills:
Validation Deliverables: VTP, VMP, URS, FRS, DS, IQ, OQ, PQ, VSR.
Regulations: 21 CFR Part 11 (210/211, 820), GAMP, cGMP, GDP, GLP, ICH.
Applications: MERP, Track wise, Empower, EMDS, QMS, SAP, My Learning.
SDLC: Waterfall, V-Model, Agile and Scrum
Business Tools: MS Office (Word, Excel, Power Point, Access, Visio, Project), Adobe Frame Maker, Minitab, HPAML, Control chart.
Document Management System: Veeva Vault, Adobe, Share point, Documentum, PDOCS.
Laboratory Instruments: Spectramax, qPCR, Dissolution Testing Apparatus, UV-VIS Spectrophotometer, GC/MS, LC/MS, HPLC, Plate readers, Roche friabilator, Franz Diffusion Cell, purified water system, Ultra Sonicator, Filtration degasser, Ovens, pH/Conductivity meters, Electrophoresis apparatus, Centrifuge, Scintillation Counter, Bio- amplifier.
Projects Insight:
Titan Pharmaceuticals, Inc.
CA
Nov2022 – Till Date
Senior Validation Specialist
Working for one of the world’s largest biopharmaceutical company, involved in developing innovative vaccines, medicines for world’s challenging diseases and animal health products. At present the main research is on development of scientific advancements for Hepatitis C, HIV, Diabetes and immuno-oncology.
This project is mainly involved in Data Integrity Remediation Plan to ensure the systems involved in the development of vaccines, pharmaceuticals and in the above-mentioned research, are in compliance with 21 CFR Part 11 and FDA regulations. Ensured the systems meet all the Data Integrity requirements which are high level security requirements that has impact on patient safety. All the data is stored using GLIMS.
Responsibilities:
Involved in documenting and developing SDLC deliverables like Requirement Specification, Configuration Specification, Requirement Traceability Matrix, IOQ/OQ in compliance with 21CFR Part11.
Acquired and documented the business requirements. Analyzed test scripts to check whether all functionalities have been covered in compliance with21 CFR Part 11.
Expertise on working with computerized based systems, to ensure all the systems ae in compliance with Data Integrity (DI) requirements.
Authored and initiated workflow for the approval of Quality Assurance Plan in MIDAS (EDMS) for approval.
Worked with vendor on installation of upgraded software Endosafe EndoScan-V and Image Lab version 6.0.1.
Worked on validating various software like Image Lab, Cary WinUV, SoftMax Pro, Endosafe EndoScan-V, epBlue, NIMBUS96, Cary UV Workstation Plus, DYNAMICS and Tiamo in compliance with 21 CFR Part11.
Proficient in diagnosing DI gaps, resolving and mitigating them.
Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating.
Authorized Quality Assurance Plan (QAP), Requirement Specification (RS), Configuration Specification (CS), Installation Qualification/Operational Qualification (IQ/OQ), Requirements Traceability Matrix (RTM) and routed into MIDAS for pre- approval.
Executed IQs, OQs and PQs to check the functionality of the system.
Tracked and maintained deviations, exceptions during execution of UAT scripts.
Authorized Quality Assurance Summary Report (QASR) for computerized systems to ensure the system met all the acceptance criteria and is ready for release into use.
Involved in the post execution documentation (as per GDP) of executed IOQ and coordinated with Business Unit, Technical Unit and Quality Assurance for post approval.
Well versed in generating and executing Qualification document for non-computerized systems.
Involved in creating Statement of Work (SOW), revision to the existing SOP’s and establishment of internal company
Standards.
Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system. Routed these SOP(s) in MIDAS for approval involving Technical Unit and Business Unit.
Responsible for ensuring the compliance of GMP/GLP and FDA regulations.
Maintained the quality of all project deliverables despite extremely aggressive timelines.
Generated Validation Summary Report to summarize and document all validation activities.
Conducted internal and external reviews, as well as, formal walkthroughs, and participated in status meeting.
Lexicon Pharmaceuticals, Inc.
Mar2022 – Oct 2022
Validation Engineer
Lexicon Pharmaceuticals is a biopharmaceutical company that has harnessed the power of genetics for drug our research team has generated a pipeline of novel drug candidates in clinical development across a broad range of indications.
Responsibilities:
Involved in coordinating the approval of IT for Insight Publisher Upgrade through authorized Request for Change- RFC.
Co-ordinated with Regulatory Operations to open a new Validated System Change Request in Trackwise to document the implementation of Insight Publisher Upgrade.
Involved in review and approval of user requirements to upgrade Insight Publisher to v 3.6.2.1.
Involved in drafting and approval of the computer validation plan for the Insight Publisher upgrade to v3.6.2.1
Worked with Vendor to install Insight patch upgrade in DEV (Development) and coordinated the information with Regulatory Operations.
Drafted the Installation Qualification Protocol (IQP) as per release notes provided by for implementation of insight Patch.
Drafted the Operational Qualification Protocol (OQP) in coordination with Regulatory Operations to test the publishing activities.
Involved in review, update and pre-approval of IQP and OQP by uploading the documents in Aegis EDMS involving System Owner, Validation, Information Technology, and Quality Assurance.
Proctored the implementation of Insight Patch upgrade in QAS (Quality Assurance System) environment using the IQP and documented any issued encountered in the form Exceptional Conditions (EC) or General Forms (GF).
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.
Involved in implementing the patch in PRD finally as per the IQP and coordinated with post approval of the document.
Assuring that the VSCR (Trackwise) and RFC (SharePoint) are in appropriate status to ensure IT Compliance as per Biolex standards to comply with FDA regulations.
Involved in the review and approval of Tardis Data Migration Plan to import the scanned or native application generated submission content files.
Authored the Computer Validation Plan and IOQ protocol for the Tardis Data Migration and involved in the pre-approval of documents in Aegis (EDMS).
Proctored, documented and coordinated approval for the successful migration of legacy content files into the Tardis system from Regulatory fileshare location.
Involved in the review and approval of CoreDossier Data Migration Plan to migrate the paper submission assembly templates into Insight Publisher system which is mainly used for electronic submissions.
Authored the Computer Validation Plan and IOQ protocol for the CoreDossier Data Migration and involved in the pre- approval of documents in Aegis (EDMS)
Proctored, documented and coordinated approval of the successful migration of paper submission templates into Insight Publisher system.
Actively involved in the successful rebuild Aegis (EDMS) webserver.
Executed and documented discrepancies found during the execution of pre-approved Performance Qualification (PQ) Protocol as part of Aegis webserver rebuild.
Involved in the drafting, pre-approval, execution, and post approval of IOQ document related to Spreadsheet Validation.
Involved in preparing the validation summary report documenting and elucidating all the discrepancies found during implementation and testing.
Sun Pharmaceuticals Mumbai IN
July2019 – Dec2021
Compliance specialist
Sun Pharma is an Indian multinational pharmaceutical company headquartered in Mumbai, Maharashtra that manufactures and sells pharmaceutical formulations and active pharmaceutical ingredients (APIs) in over 200 counties. Its global presence is supported by 40 manufacturing facilities spread across 5 continents, R&D centres across the globe and a multicultural workforce comprising over 50 nationalities.
Responsibilities:
Validated analytical laboratory equipment such as GC, HPLC, Autoclaves and Incubators in compliance with FDA regulations.
Involved in validating computer system interface with laboratory equipment such as Spectrophotometer, HPLC, GC and Autoclave.
Customized and validated different components of the LIMS modules.
Acquired and documented the business requirements.
Prepared Validation Master Plan (VMP) for validating analytical laboratory equipment and LIMS.
Hands on experience in formulating Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) for validating.
Executed IQs, OQs and PQs to check the functionality of the system.
Generated Validation Summary Report to summarize and document all validation activities.
Developed and reviewed Standard Operating Procedures (SOPs) for various functionalities of the system.
Validated and used Empower Chromatography Data Software by Waters.
Created presentation slideshows and provided training to all testers to ensure all company standards are followed during test execution.
Served as point of contact in the absence of supervisor.
Analyzed test scripts to check whether all functionalities have been covered within the compliance of 21 CFR Part 11.
Developed test scripts and test cases for automated and regression testing using Quick Test Professional (QTP).
Responsible for ensuring the compliance of GMP/GLP and FDA regulations.
Maintained the quality of all project deliverables despite extremely aggressive timelines.
Handled multiple projects and change requests simultaneously without compromising project schedules.
Assisted in generating the Error Report Form and resolving the errors encountered during the testing effort and maintained the Error logs for the errors.
Involved in creating Statement of Work (SOW), revision to the existing SOP’s and establishment of internal company standards.
Assisted in development of validation/systems compliance training on systems compliance initiatives; provided continuing compliance education support to the Global IT Organization.
Conducted internal and external reviews, as well as, formal walkthroughs, and participated in status meeting
Voyager Therapeutics, India January 2016 – June 2019
Validation Analyst/compliance expert
Voyager Therapeutics, is a US-based diversified healthcare company that is redefining healthcare value by finding solutions for the unmet needs of patients along care pathways for pain management, pelvic health, urology, endocrinology and oncology. Endo is dedicated to improving care through a combination of branded products, generics, devices, technology and services. This project involved in validation of SQL*LIMS software. The application was used to track the quality and composition of drugs during the manufacturing and testing process and for stability studies during the lifetime of the drug. The project also involved creating, reviewing, routing, and tracking documents using Documentum, and testing the functionality of environmental monitoring application (MODA), trackwise, enterprise asset management system (EAMS).
Responsibilities:
Performed and reviewed Installation Qualification (IQ) for various sites.
Gathered and finalized user and functional requirements for the LIMS application.
Performed Operation and performance qualification (OQ/PQ) for the LIMS applications.
Developed and executed Test Plans and Test Scripts based on user requirements to verify complete functionality.
Conducted Data Driven Testing using Mercury QTP.
Reported test execution using Mercury Quality Center.
Participated in drafting UAT scripts for a new release of SQL*LIMS application.
Reviewed the executed test scripts (UAT scripts) for approval.
Logged, tracked, managed, and closed change management requests pertaining to the SQL*LIMSrelease.
Raised and managed exceptions, deviations during UAT execution for the SQL*LIMS release using Trackwise.
Participated in updating and reviewing Requirements Traceability Matrix (RTM) for the new release of SQL*LIMS.
Participated in performing and communicating Risk Assessment pertaining to LIMS validation to the team.
Performed database testing using SQL queries.
Logged and tracked compliance issues and incidents using Trackwise.
Developed test scripts for testing the functionality of Trackwise.
Coordinated, led, and participated in weekly meetings to ensure timely execution of the project.
Reviewed change controls with accompanying documentation prior to approval and closure to ensure completeness, correctness, and adherence to standards.
Created, reviewed, updated, and routed documents using Documentum.
Extracted and drafted user and functional requirements for environmental monitoring application (MODA) from vendor supplied documentation (user’s guide).
Created UAT test scripts for MODA.
Tracked and maintained deviations, exceptions during execution of UAT scripts.
Created the requirements traceability matrix (RTM) for the MODA application.
Executed and reviewed the test scripts for MODA.
Executed crystal reports for various reports and labels in MODA.
Aurobindo Pharma, India January 2014 – Dec 2015
QA Analyst/Computer System Validation Engineer
Responsibilities:
•Reviewed and Analyzed the Business and Functional Requirement Documents.
•Actively participated in various meetings including Business Analysts, Development, and QA. Meetings.
•Performed initial data migration, subsequent delta migrations and validated the data been converted.
•Implementation of database security procedures, maintenance of Oracle databases using OEM, ASM configuration and movement of data across databases using data pump export/import utilities.
•Led the design and development of complex data conversion routines and data cleaning techniques for converting and migrating Lotus notes data into the new oracle database using various packages, stored procedures and functions.
•Planned and executed Test Method Validations, perform regression and HALT/HAST testing
•Created manual Test Cases in HP QC/HP ALM for various User Stories based on Release and Sprint Plan.
•Involved in daily Scrum meetings. Also involved in Iteration/Sprint planning meeting to plan the stories that needs to be developed and tested in the upcoming sprint based on the priority and estimated effort.
•Followed SOPs and Project Compliance Plan in carrying out different validation / testing activities.
•Followed Computer Systems Validation CSV Master Plan to author, review and approve CSV deliverables for systems as per GxP GLP, GCP, GMP, GDP, cGMP FDA Assessment.
•Authored, reviewed and approved CSV deliverables Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, and Validation Summary Report for Temp Tale Desktop Manager used by the Supply Chain.
•Routed computerized systems documents Validation Project Plan, URS, TM, IQ, PQ, UAT, Vendor Postal Audit Report, Computer System Risk Assessment, Periodic Review Report, Decommission Report, SOPs, and Validation Summary Report using SAP and eDOCs for review and approval.
•Analyzed Requirements and Design Documents to understand system functionality which helped in authoring and reviewing of different validation documents.
•Developed and executed System and UAT Test Scripts based on SRS and URS.
•Developed, updated and reviewed computerized systems documentation such as CSV Risk Assessment, Test Plan, Test Summary Reports, Test Scripts, Traceability Matrix, 21 CFR Part 11 Assessment, Validation Summary Reports and UAT documents in GxP regulated environment.
•Developed Test Plan and Summary Reports for System and UAT testing.
•Updated and reviewed Traceability matrix to ensure that all requirements are mapped to test Scripts.
•Documented the defects identified. Performed root cause analysis of the defects identified.
•Maintained close communication with stakeholders and team members to keep apprised of computerized system needs, impacts on computer validation, project validation status, and other relevant issues.
•Assisted in planning, implementing, and documenting User Acceptance testing.
•Reviewed Change Control documentation for the project.
•Provided guidance on quality and compliance issues that affect the integrity of the data or the system.
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