- Strong knowledge and background of Software Development Life Cycle (SDLC), familiar with Waterfall, V - shape and Agile models in relation to development and testing.
- Expertise in preparing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance with FDA regulations.
- Comprehensive knowledge and extensive experience in preparing and reviewing Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification -OQ and Performance Qualification - PQ), Test Summary Report and Validation Summary Report (VSR).
- Strong understanding of 21 CFR Part 11 GxP requirements including electronic records, electronic signatures, system validation strategies and documentation.
- Expertise in conducting High Level Risk Assessment (HLRA) and documenting as per GAMP 5 guidelines.
- Assisted with requirements traceability information and tracked requirements status throughout the project.
- Skilful in performing the Dry Runs and thorough understanding to review manage & execute test scripts manually.
- Performed and reviewed GAP Analysis and initiated the remediation action plan.
- Worked on change control documentation such as Change Request Form (CRF's), Change Control Implementation Plan, Change Control Summary Report and initiated change controls following CAPA resolutions.
- Experienced in Deviation resolution including Root Cause Analysis, CAPA closeouts and Deviation reports.
- Expertise in using automated testing tools such as HP QC/HP ALM and used JIRA for bug tracking, issue tracking and project management.
- Working knowledge of MS Office, MS Visio, MS Project, EDMS platforms, and Quality System Software.
- Excellent communication skills, both written and verbal and has ability to work with both business and technical teams.
CSV Skills: FDA guidelines, GAMP regulations, 21 CFR part 11, Part 820, GDP, GxP regulations
Validation Tools: HP ALM, TrackWise, JIRA
MS Office: MS word, MS Project, Visio, MS Excel
SDLC Methodologies: Waterfall, Agile, V-model
GxP Application: LIMS-LabVantage, LabWare, Axway
Coding Language: HTML, CSS, Drupal CMS
Confidential, Beverly Hills, CA
Sr. Validation Analyst
- Responsible for documentation of all aspects of the Computer System Validation (CSV) Life Cycle in accordance with 21 CFR Part11, xGLP and xGDP.
- Participated High Level Risk Assessment (HLRA) session to determine if the system is GxP
- Participated in Vendor Assessment for vendor selection
- Prepared work flowcharts In MS Visio to illustrate the User Requirements
- Developed Master Validation Plan for the implementation of the new application
- Involved in drafting the User Requirement Specifications (URS) and Functional Requirement Specification (FRS) by conducting meetings with the users.
- Executed risk assessment using DFMEA, PFMEA
- Authored and Documented Validation Protocol documents like Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)
- Developed and maintained Requirement Traceability Matrix (RTM) to track the requirements
- Performed dry runs to check if the test cases have covered the functionalities, which need to follow 21 CFR Part 11 rules set by FDA.
- Lead the team in the formal test execution of test scripts and documented the deviations
- Involved in GAP analysis for user requirements verification and devised remediation plans
- Performed deviation investigations, root cause analysis, and implemented CAPAs to business units which improved efficiency in accordance to compliance
- Authored End-User Training Manuals and SOP's
- Prepared and documented Validation Summary Report (VSR) including Deviation investigation, Resolution and Quality System Development
- Gathered the Business Requirements to move from the legacy system to new system
- Authored Data Migration Strategy and Plan
- Prepared Source to Target Detailed mapping document & Transformation rules document
- Participated in pre-migration testing and post-migration testing
Confidential, Bridgewater, NJ
Sr. Validation Analyst
- Assisted with requirements gathering and process mapping phases, including elicitation and documenting of business, system, and functional requirements.
- Reviewed Validation Master Plan (VMP) and Validation Protocols (IQs, OQs and PQs) in detail.
- Developed Validation Test Plan in conjunction with FDA regulations.
- Reviewed tools for LIMS decision support to be used by the site. Analysis of LIMS enhancements, troubleshooting issues, second tier application support and routine master data configuration as required within the LabVantage LIMS application.
- Developed the Requirement Traceability Matrix (RTM) document to map the test steps with the User and Functional Requirements.
- Base line the test plan, test criteria & Project Schedule by walkthroughs and reported the defects using HP ALM
- Used HP ALM for the testing and for tracking and reporting test defects.
- Initiated laboratory investigation and performed Root Cause Analysis and implemented CAPAs to remediate discrepancy events.
- Involved implementation of the Biobanking module in LIMS and its execution, and comprehensive system to store and maintain all specimens.
- Authored various validation deliverables like Test Plan, Test Summary Report and Final Validation Report maintaining company standards.
- Experienced and in-depth understanding of all system lifecycle deliverables from Commissioning, Qualification and Computer System Validation (CSV) documents through System Retirement.
Confidential, Deerfield, IL
Sr. Computer Systems Validation Analyst
- Reviewed User Requirement Specifications (URS) and Functional Requirement Specifications (FRS), and verified the User Requirement mapping to the Business Process Workflows.
- Analyzed the Business requirements and prepared the Process Validation Master Plan.
- Worked with multi-departments to carry out the vendor assessment & validation activities.
- Assisted the Business team in capturing the regulatory scope of the TrackWise QMS application by means of High-Level Risk Assessment (HLRA).
- Maintained 21 CFR Part 11compliance for computer systems by conducting Risk Assessments, identifying compliance gaps, and developing Remediation Plans.
- Ensured requirements that are Critical to Quality (CTQs) are defined, understood and aligned with current capabilities.
- Developed the Electronic Records and Electronic Signatures Assessment document by performing Part11 assessment to the components involved in maintenance of Electronic Records, Electronic Signatures and Audit Trails in accordance with 21CFRPart11 regulations.
- Used JIRA tool to track issues/bug and manage the project.
- Prepared Deviation Reports when the test criteria did not meet the acceptance criteria.
Confidential, Smyrna, GA
- Interacted with end users to understand business processes and gather requirements.
- Assisted in creating User Requirement Specification and Functional Requirement Specification documents.
- Actively participated in project meetings and discussions.
- Checked the system for compliance with the FDA regulations, 21 CFR Part 11, and maintained the electronic records and signatures.
- Developed validation and quality assurance programs including templates for validation related documentation such as Validation Protocols, Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ).
- Performed Dry runs and Formal Executions on the application to test the integration of the Axway with multiple printing solutions for labelling.
- Prepared Test plans, Test cases, Test Summary Report and traced requirements using traceability matrix.
- Made deviation investigations, SOP and quality system development, and documentation control and equipment/facility qualification.
Confidential, Somerset, NJ
Validation Engineer/ Technical writer
- Involved in all phases of Computer System Validation (CSV) Life Cycle to comply with FDA regulations particularly 21 CFR Part 11.
- Performed Risk Assessment and proposed improvement suggestions on Validation processes.
- Involved in developing protocols for IQ, OQ and PQ and developed test data and templates for their execution in Custom Configured LIMS environment.
- Configured modules and gathered requirements for the LabWare LIMS.
- Responsible for developing Standard Operating Procedures (SOPs) referring to 21CFR Part11 for LabWare LIMS (Laboratory Information Management Systems).
- Ensured the documentation of validation activities was as per Good Documentation Practices (GDP) for regulatory agency submissions.
- Managed the qualification effort of LabWare LIMS by conducting dry runs on the operational and performance testing protocols and documented the results for effective qualification effort.
- Developed Traceability Matrix to track requirements for the software application module.
- Worked in coordination with the Business Analysts, IT members, validation team members and group managers to discuss and eliminate the various issues for a successful completion of the project.
Confidential, Dublin, CA
Equipment Validation Engineer
- Involved in developing Process flows, Requirements Documents, Configuration documents and Design Specifications.
- Assisted in Factory Acceptance Testing (FAT), Site Acceptance Testing (SAT) and User Acceptance Testing (UAT) documentation.
- Involved in all Testing activities IQ, OQ, PQ test script preparation and test executions including deviations management.
- Worked with CAPA team in investigating and identifying the root cause of deviations and prepared deviation reports.
- Reviewed the Design History File (DHF) that summarizes the design and development processes.
- Reviewed user training log, user log, user manual, technical support manual, calibration records and preventive maintenance records for alignment with the SOPs.
- Assisted in procedure development and maintenance, capability studies, Gauge R&R, first article reports.
- Prepared Validation Summary Report (VSR) and Requirements tractability Matrix (RTM).