DIVYA POLASA
Atlanta,GA
Summary
- Extensive experience as a Quality Assurance/Validation Engineer with expertise in GxP Systems.
- Strong understanding of 21 CFR Part 11,210, 211, 820, validation strategies and related documentation, ISPE Guidelines, and Best Practices.
- Skilled at new lab installations and lab instrumentation upgrade activities.
- Knowledge of conducting re-validation and remediation activities.
- Skilled at performing Data Integrity (DI) assessments and resolving DI gaps.
- Very proficient in Authoring, reviewing, and implementing Validation Deliverables – Validation Plan, Test Plan, Risk Assessments, Regulatory assessments, Validation and test summary reports, and Protocols (Installation Qualification (IQ), Operational Qualification (OQ) & Performance Qualification (PQ)).
- Experience in preparing and reviewing Requirements Traceability Matrix (RTM).
- Experience in validating Lab Instruments –Refrigerators, Density meter, Filter Integrity Testers, Dissolution, Spectrophotometers, Glove Testers, High-Performance Liquid Chromatography (HPLC), Gas Chromatography (GC), Mass Specs, PH Meters, Plate Readers, Balances, Stability Chambers, Incubators, Microscopes, Freezers, Autoclaves, Distillation Machines, Infra-Red Spectroscopy, Polymerase Chain Reaction (PCR) Machines, Total Organic Carbon Analyzers (TOC), Autoclaves, Water Purifiers, Auto Samplers, Air samplers, Spectrophotometers, Cell/sperm counters, Slide stainers/slide scanners. Good knowledge of labeling software, BarTender, Spreadsheet/excel validators, einftree, and XLValidator.
- Good Knowledge of Building Management Systems (BMS), SCADA, DeltaV, ERP Systems, Systems, Applications and Products (SAP), Spectrum 10, Documentum, Empower, Labware LIMS, LabVantage LIMS, Electronic Lab Notebook, Siebel (Sample Management module), Complaint Investigation and Management System, Provantis, TraceLink, Serialization, TrackWise (RCA, Change Control Management), and Web Applications.
- Good knowledge of Validation Lifecycle Management Systems (VLMS), ValGenesis, Kneat, JIRA, and HP ALM. Thorough knowledge of Good Documentation Practices (GDP) and GxP Regulations (21 CFR Part 11, 211, 820).
- Managed demanding and fast-paced projects via Agile, Waterfall, and V- Methodologies.
- First-hand experience in developing comprehensive Test Strategies for different GxP Systems.
- Hands-on experience using temperature mapping equipment (Kaye Validator) and knowledge of Z-scaler.
- Strong Understanding of Change Control Methodology and Information Technology Infrastructure Library (IT-IL) Guidelines.
- Drafted, monitored, and reviewed Standard Operating Procedures (SOPs), policies, and working instructions to comply with FDA regulations. Knowledge of refrigerator and freezer operation and temperature distribution patterns in storage spaces.
- Experienced in performing periodic reviews and GAP analysis in identifying compliance gaps, developing corrective action and preventive plans (CAPA), and implementing those corrective action plans.
- Actively participated in audits for existing Validation documents and drafted an audit report and suggestions based on the best practices in the industry.
- Excellent interpersonal, organizational, verbal, and written communication skills. Experience in supporting audits and assessments on documents and systems.
Overview
9
9
years of professional experience
Work History
Systems Analyst
Vensai Technologies
01.2025 - Current
- Perform system analysis and design and development activities in support of business processes.
- Utilize Agile methodology principles throughout the software development life cycle.
- Facilitate between business units to address and resolve IT software issues.
- Evaluate current processes, identify areas for improvement, and recommend management changes.
- Work with computer systems and programs.
- Test, maintain, and monitor computer programs and systems and coordinate installation of computer programs and systems.
- Conduct functional testing of software applications to ensure proper operation.
- Provide technical guidance on new system implementations and enhancements.
Validation Engineer
AmplifyBio
04.2023 - 01.2025
- Provided validation strategies for Laboratory instrumentation (various analyzing instruments, slide stainer, and slide scanner) and associated GxP systems.
- Involved in the validation of whole slide image storage and review systems, raw data analyzing systems, and responsible for drafting and reviewing the GxP applicability assessments, 21 CFR part 11 Assessments, and gathering requirements
- Performed end-to-end validation activities of various GxP systems.
- Documented, reviewed, and approved validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts, and discrepancies
- Ensured product and process development activities have all necessary validation and supporting justification.
- Worked on archiving validation packages
- Assisted with developing and implementing protocols to support the validation activities according to requirements.
- Managed the overall documentation development and approval process from a quality and validation standpoint
- Participated in Investigations and Root Cause Analyses for deviations in various equipment and process-related issues
- Drafted and reviewed deviations and Change controls in Veeva Vault.
- End-user experience managing document workflow in Veeva Vault and ValGenesis Document Management systems
- Reviewed and updated SOPs/ Work Instructions for Infrastructure IT Controls, including Backup and Restore, Server Configuration and Qualification, Disaster Recovery, Network User account creation and maintenance
- Partnered with Quality Assurance personnel to review and approve validation deliverables
Computer System Validation (CSV) Lead
National Resilience
10.2021 - 03.2023
- Provided validation strategies for Laboratory instrumentation (Refrigerators, Density meter, Karl Fisher Titrators, Dissolution, Spectrophotometers, Freezers, HPLC, Filter Integrity Testers) and associated systems GxP Systems.
- Validated and end user experience managing documents in Kneat, Veeva Vault, and MasterControl document management systems.
- Led laboratory instrumentation installations, data migration, and upgrade activities.
- Performed risk assessments and gap analyses and resolved data integrity gaps.
- Conducted and monitored remediation activities for all existing laboratory equipment
- Provided guidance and support to the support teams on compliance and quality requirements.
- Assisted with developing and implementing protocols to support the validation activities per requirements.
- Documented, reviewed, and approved validation documentation, including assessments, validation plans and reports, requirements, specifications, protocols and reports, test scripts, and discrepancies.
- Ensured product and process development activities have all necessary validation and supporting justification.
- Ensured validation processes were performed according to the organization's policies, procedures, and directives.
- Performed pre-approvals and post-approvals on IQ/OQ/PQ test cases
- Reviewed and executed UAT, FAT, SOPs, and Engineering Change Requests for new or modified manufacturing equipment, processes, systems, facilities, and Utilities
- Reviewed Requirements Traceability Matrix to ensure all requirements are thoroughly tested
- Ensured 21 CFR Part 11 and risk assessments were performed on all systems and released to production per local and global policies and procedures.
- Supported audit activities by reviewing the required documentation and gaps
- Acted as a point of contact for all validation needs from the client and team relationship standpoint.
- Developed technical change controls for all laboratory equipment standpoints.
- Managed the overall documentation development and approval process from a quality and validation standpoint.
- Participated in Investigations and Root Cause Analyses for deviations in various equipment and process-related issues.
- Reviewed deviations and CAPAs in Veeva Vault.
- Reviewed and updated SOPs/ Work Instructions for Infrastructure IT Controls, including Backup and Restore, Server Configuration and Qualification, Disaster Recovery, Network User account creation and maintenance
Sr. Validation Engineer
Sanofi
11.2020 - 10.2021
- Validated HPLC, GC, Mass Specs, FTIR, DSC, PH Meters, Plate Readers, Balances, Stability Chambers, Incubators, Microscopes, Freezers, Autoclaves and Distillation Machines
- Designed and executed laboratory validation to ensure consistency of data production and compliance with client's quality standards
- Ensuring laboratory installation and development activities have all necessary validation and supporting justification
- Developed technical documents in a simple and compliant manner
- Ran IQ/OQ and PQ test scripts and made design or process modification recommendations based on test results
- Performed and documented vendor audits in identifying the lab Instruments
- Documented, reviewed, and approved 21 CFR Part 11 Assessment and GxP Risk Assessments
- Develop requirements that facilitate the hardware, software, and vendor selection for the lab instruments and their associated software to be installed
- Reviewed FAT, SAT and User Acceptance Testing (UAT) documentation
- Developed standard methods for identifying the frequency of periodic reviews of lab instruments
- Developed Impact Assessments and Risk Analysis documents
- Conducted System level and Functional Level Risk Assessment Sessions with the team to identify potential gaps
- Developed Standard Operating Procedures and Work Instructions
- Developed Decommissioning Activities for various lab instrumentation
- 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
- Liaise with business unit and quality/compliance functions to ensure regulatory requirements are well understood and documented
- Worked with the CAPA team to root out the cause of issues and prepare deviation reports
- Developed/Maintained the Requirements Traceability Matrix (RTM)
- Maintained Training Logs and Incident/ Test Case Assignment logs
Validation Engineer
Nobel Biocare
09.2018 - 10.2020
- Developed and executed Validation Protocols (IQ, OQ, and PQs) for Lab Instrumentation and its associated Software
- Developed and executed IQ, OQ, PQ documents, User Acceptance Testing (UAT), FAT, SOPs, and Engineering Change Requests for lab systems
- Developed Standard Operating Procedures, protocols, incidents, and final reports for new processes and equipment in conjunction with the system owners
- Supported department projects by assisting senior engineers on ongoing projects
- Developed and executed Lab Equipment Qualification plans and protocols for manufacturing and packaging equipment
- Created and executed commissioning, qualification, and validation protocols (CP/IQ/OQ/PQ/PPQ), including identifying and resolving exceptional conditions
- Authored user and functional requirement specifications, data migration plan, IQ, OQ, PQ protocols, scripts and qualification reports, validation reports, etc., for new equipment and software, enhancements, maintenance releases, upgrades, and periodic reviews
- Prepared and reviewed the Validation Master Plan (VMP) and Validation Summary Report (VSR)
- 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
- 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) to support Validation
- Performed Regulatory Assessment and Risk Assessment for the Computer Systems
- Performed GAP analysis and developed Remediation plans
- Wrote and executed IQ, OQ, and PQ Protocols
- Analyzed system requirements and developed Test Plans and test Scripts
- Responsible for performing UAT for the application
- Followed GDP guidelines to record and report test results
Validation Consultant
BPL Plasma
02.2016 - 06.2018
- Identified validation requirements to ensure Compliance and Quality aspects.
- Developed User Requirements Specifications for Lab Instruments.
- Worked with vendors on system architecture and instrumentation.
- Involved in vendor coordination and developed technical support manuals, work instructions, and SOPs.
- Performed feasibility analysis on requirements and testability.
- Documented and executed validation and re-validation protocols and reports (IQ / OQ / PQ) to validate new and existing equipment.
- Coordinated completion of corrections to history records and related documents.
- Performed internal audits and approved deviations/investigations/CAPA/OOS.
- Maintained and monitored the maintenance of quality systems and cGMP compliance.
- Involved in Change Control Management activities.
- Developed 21 CFR Part 11 Assessments and GAMP category Assessments.
- Reviewed documentation quality per the standard provided.
- Developed the validation strategy document for the concept and planning phase of the project.
- Performed investigation into process deviations, created reports, and implemented corrective and preventive actions.
- Documented the deviations and investigated the root cause and impact on the product, process, or system.
- Participated in cross-functional teams to identify root causes and facilitate approval and closure of the incident report
Education
Completed coursework towards Masters - Public Health
University of Alabama at Birmingham
Completed coursework towards Masters - Information Technology
University of Cumberlands
Timeline
Systems Analyst
Vensai Technologies
01.2025 - Current
Validation Engineer
AmplifyBio
04.2023 - 01.2025
Computer System Validation (CSV) Lead
National Resilience
10.2021 - 03.2023
Sr. Validation Engineer
Sanofi
11.2020 - 10.2021
Validation Engineer
Nobel Biocare
09.2018 - 10.2020
Validation Consultant
BPL Plasma
02.2016 - 06.2018
Completed coursework towards Masters - Information Technology
University of Cumberlands
Completed coursework towards Masters - Public Health
University of Alabama at Birmingham
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