- Over six years of experience in Computer Systems Validation in Pharmaceutical Industry under FDA regulations with a strong base in Software Quality Assurance, Business Analysis, Change Management.
- Experience in developing and reviewing Validation Protocols: Installation, Operational and Performance Qualifications (IQ, OQ and PQ), Validation Summary Reports, Data Migration Plans/Summary Reports and writing Standard Operating Procedures (SOP).
- Experience in developing and writing Business Requirements, Functional Specifications using UML modeling.
- Experience in creating entire suite of Software Development Lifecycle (SDLC) deliverables and QA Methodologies.
- Familiarity with Gap Analysis and Solid analytical skills and ability to do Root Cause Analysis of situations with an in-depth evaluation of various factors.
- A good understanding of GLP, GCP, GMP, 21 CFR part11, 210, 211, 820 as related to the FDA regulations and Annex11 related to European regulations.
- Excellent knowledge in developing and reviewing Traceability Matrix.
- Experience in performing Risk based Validation
- Proficient in Validation of Laboratory Instruments like UV Spectrophotometers, HPLC's.
- Good knowledge of CTMS, EDC, ARISg, LIMS
- Ability to comprehend technical information related to HPLC and Spectrophotometers.
- High level of familiarity with MS Office tools like Excel, Word, Access, Visio and PowerPoint, SharePoint, HP Quality Center and QTP.
- Excellent oral and written communication skills and ability to work both independently and in a team.
BUSINESS TECHNICAL SKILLS:
Software Development Life Cycle (SDLC), UML modeling, SharePoint, RequisitePro, MS Word, MS Excel, MS Access, MS PowerPoint, MS Visio.
Confidential, Commack, NY
Business Analyst/ Validation Specialist
Confidential is a U.S. pharmaceutical company specializing in mid to late stage drug development in CNS, respiratory, cardio-vascular, pain, infectious diseases, and other prescription medications. The project involved creating Business objects report for periodic reporting of drugs under development in a common standard format to FDA and EMA.
- Involved in validating reports generated from data in the drug safety database.
- Prepared and executed validation protocol documents like IQ, OQ, PQ.
- Developed Test plans and Test scripts.
- Followed SOPs and provided technical support to the testing team in defining test strategies, reviewing test scripts for correctness and completeness, supporting test execution and reviewing test results.
- Configured test environment including setting up of test data, Approve results documentation and tracking systems updates.
- Developed traceability matrix to track requirements for the software application module.
- Supported UAT activities by training users on UAT test scripts, reviewing them for completion.
- Involved in tracking deviations and resolutions prior to the system release into production.
- Prepared defect reports and presented progress updates at defect report meetings.
- Involved in document management and project management through SharePoint.
Confidential, New Jersey
Business Analyst/Validation Consultant
Confidential is a pharmaceutical company currently involved in developing, manufacturing and marketing a broad range of products. The project involved integrating the Drug shipment tracker with the CTMS for drug request and tracking of shipment. Another project involved creating interface between EDC and TrialTrak (internal application used to track Clinical Trials related data)
- Involved in user and business requirements gathering and preparing Business Requirement Documents describing the essential business processes.
- Participated in Joint Application Development (JAD) sessions with management, SME (Subject Matter Experts), vendors, users and other stakeholders for open and pending issues to develop specifications.
- Participated in the design sessions to understand the limitations and the capabilities of the business
- Planned and defined system requirements through Use Cases, Use Case Scenarios and Use Case Narratives using the UML (Unified Modeling Language) modeling.
- Identified source systems, related tables and fields and ensured data suitability for mapping during audit.
- Created and reviewed Validation Deliverables for Data Integration between Clinical Trial Management System (CTMS) and Drug Shipment Tracker and also between TrialTrak and Electronic Data Capture (EDC)
- Responsible for writing IQ/OQ/PQ documents.
- Involved in writing Validation Plan, URS/FRS, Design Specification, Test scripts, Traceability Matrix, Summary Reports.
- Followed cGCP regulations to validate the system.
- Conducted User Acceptance Testing on the application – resolved issues from the participants, prepared and submitted Test Analysis Reports and participated in product readiness review.
- Involved in writing deviation reports and making recommendations for corrective actions.
- Managed change control request and re-validation program through active contribution in the development and review of associated critical documents.
- Participated in periodic review process and documented periodical evaluation report.
Confidential, New Jersey
Business Analyst/Validation Consultant
The aim of the project was to migrate data for Chromatography Data Systems.
- Designed the data migration specification and migration plan as per the FRS for Chromatography Data systems.
- Ensured data migration as per compliance and implemented cGLP and cGCP during the testing.
- Involved in gathering business requirements and preparing BRD
- Reviewed and developed Quality System components including Master Validation Plan, Traceability matrix, SOPs and Change Control requests
- Worked extensively with the QA team for designing Validation Plan, User Requirement Specification, Functional Requirement Specification, high level test objectives and Test Scripts.
- Prepared and reviewed software validation protocols IQ,OQ,PQ
- Participated in periodic review process.
- Involved in writing SOPs for Documentation Management and Control and Change Control Process
- Wrote System Configuration Specification and Validation summary report.
- Maintained the Requirements Traceability Matrix (RTM) and frequently updated it to map all the requirements.
Confidential, Hauppauge, NY
Confidential manufactures vitamins and supplements. As a validation analyst I was involved in writing and reviewing Reports Validation Protocols for various laboratory instruments like HPLC, UV-Vis etc.
- Involved in reviewing and writing User requirements and Functional specifications for Reports generated by various lab instruments
- Managed and documented requirements using Requisite Pro.
- Responsible for writing Validation Deliverables and involved in validation of various lab instruments, including FTIR, UV- Vis Spectrometer, HPLC.
- Prepared a detailed validation test plan and test criteria.
- Supervised and analyzed validation test scripts and checked its compliance with FDA.
- Validated Audit Trail functionality and Chromatographic Data Security Mechanism to facilitate accurate and ready retrieval of documents.
- Wrote documentation for all aspects of the computer systems validation lifecycle in accordance with CFR 21 Part 11 including IQ, OQ, PQ.
- Experience in writing SOPs for Computer Systems Test Deviation Identification and Resolution.
- Made deviation investigations and created remediation plan and quality system development and equipment qualification.
- Prepared UAT test cases, coordinated with the UAT Team and participated in UAT.
Confidential is a pharmaceutical company, manufactures generic pharmaceuticals and active pharmaceutical ingredients, generics, drug discovery and consumer health care products. The company is involved in discovery and development of antibiotics, anti-retrovirals, cardiovascular products, central nervous system products, gastroenterologicals, and anti-allergics
- Documented adverse event reports from clinical trials and post-marketing.
- Ensured completeness, legibility and validity of incoming reports.
- Data entry of case reports into tracking database.
- Assessed case reports for seriousness, causality and expectedness.
- Created and maintained project specific working files, case report files.