SUMMARY

• Over 5 years of validation experience in Computer Systems, Quality Systems and Instruments / Equipment’s in Pharmaceutical, Medical Devices and Biotechnology Industries, with profound knowledge of current validation practices, predicate rule, FDA, 21CFR Part 11(210/211), cGXP (cGMP, cGCP, cGLP),, SOPs, PV,SDLC. Possess diverse experience in Technical Writing and Validation Analysis.

TECHNICAL SKILLS:

Computer System Validation: FDA compliance, 21 CFR Parts (11, 58, 210, 211, 820), GxP, VMP, VSR, IQ/OQ/PQ, SOP, RTM, SOX, Audit Trails, Gap Analysis, SDLC, VLC

Software: LIMS, AERS, Documentum, TrackWise, Sharepoint, Quality Tracking System, ARGUS Safety Management System

Operating System: MS Windows

Laboratory Equipment: HPLC, GC, Autoclaves, Sterilizers, Incubators

Others: MATLAB, Advanced knowledge of MS Office(Word, Excel, Access), Adobe Acrobat

Programming: C, C++,Java

Methodologies: Agile, Waterfall

PROFESSIONAL SUMMARY:

Confidential, Deerfield, IL

Validation Analyst/Technical Writer

Responsibilities:

• Involved in the computer system validation (CSV) lifecycle, which matches with FDA regulations particularly 21 CFR part 11 and validation requirements like reporting features, password regulatory rules, password aging and session time - out for the LIMS system.
• Involved in validation of Labware LIMS and OpenLab including editing and review of protocols and post execution review for IQ and OQ effort. .
• Conducted operational testing of Labware LIMS software and involved in writing of Operational Qualification of various LIMS modules.
• Excellent knowledge of internal company standards and GCP, GMP and GLP guidelines.
• Performed 21 CFR Part 11 GAP Analysis, Risk Analysis, Developed Requirements, Traceability Matrix (RTM) to track requirements for the software application module. Validated LabWare LIMS to meet 21 CFR Part 11 FDA Regulations.
• Involved in validation of LabWare LIMS by developing, executing and documenting SOPs, Test Plans and Test Scripts.
• Responsible for validating various LabWare LIMS features such as like Labstation, Instrument Manager, Folder Manager, Business Reports and Standards and Reagents Manager.
• Authored and reviewed the URS, FRS, Trace Matrix, Master Data and PQ protocols of LIMS validation effort for Wyeth sites in Puerto Rico, Brazil and Mexico.
• Organized schedules, determined priority status, identified responsible individual(s) and project descriptions according to company standards.
• Developed Traceability Matrix matching URS and UAT for various release efforts for Labware LIMS. Executed OQ and PQ test scripts and generated Test Summary Reports. Interacted with the Lead user and wrote PQ scripts and was responsible for User Acceptance Testing (UAT).
• Followed the principles of Software Development Life Cycle (SDLC) and was effective in improving the total quality of the software. Developed and reviewed Validation OQ Summary Report.
• Created and maintained validation documentation for assigned projects.
• Involved in preparation of Validation Deliverables (Validation Plan, URS, FRS, IQ/OQ/PQ Test Scripts, Test Cases and Validation Summary Report) of involved systems software and TrackWise.
• Designed Validation Plans, oversaw execution of the plans and reported validation activities on Validation Summary Reports.
• Prepared and executed Validation Protocol documents like IQ, OQ, PQ and User Acceptance Test.
• Managed compliance with 21 CFR Part 11 for assigned systems through Gap Analysis and Remediation Plan.
• Determined the need for revalidation based upon changes to systems.
• Review internal documentation for compliance with regulations and industry guidelines.
• Contribute to the overall development and maintenance of policies and procedures as related to compliance activities.
• Involved in document management and project management through SharePoint.

Confidential, Trumbull, CT

Validation Test Engineer

Responsibilities:

• Successfully delivered the Functional Specification document, Design Specification, Installation Qualification and Operational Qualification document by writing and editing them in MS Word for the migration of Device Attributes data from sources like Mergers & Acquisition, Product Catalog, Agile Integration and JD Edwards Enterprise One to the Master Data Management via Informatica Cloud and Oracle Database Public Schema.
• Working with Information Systems to write and execute the Installation/Operational/Performance qualification tests in MS Word for UDI program; following strict GXP according to quality procedures and test standards in accordance with 21 CFR Part 11 and Predicate Rules.
• Simultaneously working in SSG (Surgical Solutions Group), APCI (Agile Product Collaboration and Implementation) and RMS (Respiratory and Monitoring Solutions) instances which are different instances of the UDI program.
• Reviewing and providing the data mapping and transformation guidance for the script development process to load the Class III SKU data from PMDM Public Schema to GHX using PTC Windchill template.
• Working with QA/Validation department for document reviews and approvals in accordance to FDA regulatory compliance.
• Modeling requirements, managing and communicating requirements throughout the project life cycle

Confidential .Danbury, CT

Jr. Validation Analyst / Technical Writer

Responsibilities:

• Author and review GxP System Functional Tests for all Confidential modules like Products, Registrations, Manufacturing & Supply Chain, Regulatory Intelligence, Queries and Reports, Quality Management in Test Plan and Test Lab of Quality Center.
• Review Business Process Documents and Technical Functional Specifications (Design and Configuration) documents for the Register modules.
• Create and review Requirements Traceability Matrix, in order to Trace Functional Requirements with Design specifications for all Register Modules.
• Pre-Approvals and Post-Approvals of User Acceptance Tests from compliance perspective and address the Test Problem Reports/Deviations during the execution.
• Guide the Validation / Vendor team to Address, Approve and Close Test Problem Reports/Deviations during the execution of System Functional Tests using the Defects Module in HP Quality Center.
• Analyze validation test data and documentation to determine whether systems or processes have met Validation criteria by following GAMP 5, FDA 21 CFR Part 11, Part 820, and GxP regulations.
• Prepare detailed reports based on results of validation and qualification tests of procedures and protocols.
• Involved in preparing Validation Master Plan (VMP) and test plan.
• Developed Technical Documentation such as technical manuals, data flow diagrams, requirement documents etc.
• Developed FDA and GMP compliance documentation
• Developed Process/Procedures (SOP-Standard Operating Procedures) standards documentation
• Developed Installation guides and Release Notes for the Released Application
• Conducted Software/documentation usability tests
• Performed and implemented technical and peer reviews of product documentation
• Coordinates, assigns, tracks, and assesses multiple documentation projects
• Was involved in documentation during various stages of the AERS validation lifecycle, in accordance with FDA regulations, including 21CFR Part 11.
• Provides status updates on projects as required by management
• Worked closely with users and the vendor to understand and document user requirements, and functional design specifications.
• Developed and implemented validation and quality assurance programs including Standard Operating Procedure (SOPs) governing validation activities; templates for validation related documentation such as validation protocol and plans, Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ)
• Provided QA oversight to the developers and facilitated the development and implementation to meet the requirements of 21CFR Part 11.
• Involved in updating the Testing Methodology for the QA department and generating various documents to provide uniformity in the execution and reporting of tests.
• Participated in documentation of the Validation Summary Report.