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System Validation Analyst Resume

5.00 Rating

Medford, MA

SUMMARY

  • 7 Years’ Experience in Validation in FDA regulated Life Science Industry with concentration in Computer System Validation (CSV), Process Validation, Equipment Validation, Enterprise Resource Systems (SAP and JDE), and Technical Writing.
  • Professional experience in validation practices with good understanding of GAMP 5, cGxP (cGMP, cGLP, and cGDP) standards, Corrective and Preventive Actions (CAPA) Investigation.
  • Excellent knowledge on HP Quality Center (11.0) (Pre - Approval and Post-Approval of Test Scripts) and SharePoint
  • Extensive knowledge of FDA 21 CFR Part 11: Electronic Records and Electronic Signatures, 21 CFR Part 820, and 21 CFR part 210 and 211.
  • Excellent knowledge and good working experience on preparing the Risk Assessment documents
  • Expertise in developing and documenting all the aspects of Validation Plan (VP), Standard Operating Procedures (SOP), Installation Qualification (IQ)/Operation Qualification (OQ)/Performance Qualification (PQ), and Validation Summary Report (VSR)
  • Experience in developing User Requirement Specifications (URS), Functional Requirement Specifications (FRS), Software Design Specifications (SDS), Hardware Design Specification (HDS), and User Manuals of all the computerized systems and Laboratory instrumentation.
  • Strong analytical, debugging, troubleshooting skills and quick learning abilities.
  • Experience in developing and writing Requirements Traceability Matrix (RTM)
  • Experience in writing and developing Test Plans, System Functional Test Scripts, and Test Summary Reports of all the laboratory equipment’s.
  • Skillful in carrying out Gap Analysis and performing Remediation Planning
  • Excellent documentation skills in compliance with Good Documentation Practices (GDP)
  • Excellent Organizational, Interpersonal, Written, and Oral communication skills

PROFESSIONAL EXPERIENCE

Confidential - Medford, MA

System validation analyst

Responsibilities:

  • Developed the Validation Assessment Plan for the management to provide them a brief review of objectives (Validation Deliverables and Level of Testing) to be captured during validation of SAP Implementation.
  • Review and Approval of Business Process Definition (Requirements) and Technical Functional Specifications (Design and Configuration) documents for Plant Maintenance and Manufacturing Execution in Solution Manager.
  • Review and Approval of Test Plan to include all the System Functional Tests from different modules Plant Maintenance, Manufacturing Execution, Quality Management, and Warehouse Management.
  • Review and Approval of System Functional Tests for Plant Maintenance and Manufacturing Execution in HP Quality Center
  • Pre-Review of Test Scripts in HPQC (Test Plan) to verify the Description / Action, Expected Results are traced to the correct Functional Requirements
  • Post-Approval of Test Scripts in HPQC (Test Lab) to verify the Actual Results match the Expected Results and verify the Objective Evidence
  • Review and Approve Requirements Traceability Matrix (RTM) to Trace Functional Requirements to Design to Testing Protocols
  • Guide the Validation team to Address Deviations during the execution of System Functional Tests using the Defects Module in HPQC.
  • Link the Deviations to System Functional Tests, Pre-Approve deviations in HPQC and close the deviations once the Resolution is completed.
  • Review and Approve the Test Summary report to include the Summary of Testing and Deviations encountered during testing.
  • Review and Approval (Pre and Post Approval) of User Acceptance Tests from a Compliance Perspective.
  • Authored the Validation Summary Report to capture the Developed Validation Protocols and verify that the Acceptance Criteria as established in the Validation Plan is met
  • Reviewed Quality System Procedures (QSP’s) to define the Validation Life Cycle and supporting activities for Computerized System Life Cycle Process
  • Developed Templates for Authoring Validation Documents and Test Protocols.
  • Participated in preparing and presenting weekly presentations for the updates and progress of the project deliverables

Confidential, Bridgewater, NJ

Validation Analyst

Responsibilities:

  • Responsible for providing Software Quality Assurance (SQA) engineering support for all lifecycle phases of computerized systems.
  • In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
  • Enforce the company’s Quality Standards and Procedures for Computerized Systems, as defined in their governing Quality Management System.
  • Implementing and enforcing company policies and procedures for software quality assurance directly contributing to quality deliverables.
  • Participate in the validation of Computerized Systems such as, but not limited to, Enterprise Software, Crystal Reports, Automated Equipment, Regulated Spreadsheets, Medical Device Test Fixtures, and R&D Systems.
  • Help implement risk-based System Validation, Process Validation, and Software Validation.
  • Provide interpretation and guidance on various SDLC methodologies.
  • Participate in department quality improvement initiatives and actively apply software QA methodology standards.
  • Directly support QA initiatives for planned and unplanned software releases.
  • Create, maintain, summarize, review, and approve QA related-documentation against quality-document attributes, including but not limited to good documentation practices, completeness, traceability, accuracy, coverage and testability of system requirements, software defect detection, compliance risk mitigation, change management, roles and responsibilities.
  • Collaborate with Product and project management teams on system-related enhancements as well as issue resolution.
  • Review business and technical designs, mock-ups, and other work products for new functionality/features and provide feedback as needed.

Confidential - Mahwah, NJ

Validation Analyst

Responsibilities:

  • Guided the Project Management/Validation Team to develop Master Validation Plan and the deliverables required for Implementation of JDE from a Compliance Perspective.
  • Performed requirements gathering sessions with users for different modules such as Logistics, Production, Quality Assurance, Customer Service, and Information Technology
  • Analyzed the requirements and critical areas of the JDE to setup and execute baseline tests based on the System Risk Analysis
  • Developed the System Configuration Specification’s Document to capture the Configuration Settings, Hardware Configurations, Operating System Platform, and Executable Files
  • Create validation schedules; coordinate execution efforts with Subject Matter Experts, Operators, Engineers, Lab Scientists and Quality Assurance Staff Members
  • Developed Installation Qualification, Operational Qualification, and Performance Qualification Documents based on the User and Functional Requirement Specifications
  • Post-Execution Review of the Executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Documents
  • Developed Requirements Traceability Matrix (RTM) to trace the User and Functional Requirements to Test Scripts in the IQ’s, OQ’s, and PQ’s.
  • Address deviations using the Protocol Deviation Form and completed the Qualification Reports once the IQ’s, OQ’s, and PQ’s are Executed
  • Authored the Validation Summary Report to capture the Developed Validation Protocols and verify that the Acceptance Criteria as established in the Validation Plan is met
  • Participated in preparing and presenting weekly presentations for the progress of the project
  • Participated in periodic review process and documented Periodical Evaluation Report.

Confidential

Quality Analyst

Responsibilities:

  • Prepared Validation protocols for Equipment Qualification and Cleaning Validation.
  • Approved and reviewed standard operating procedures (SOP) for various processes and equipments.
  • Validated laboratory equipment’s such as multicoaters, gas chromatograph’s, and spectrophotometer’s in QC Analytical & Microbiological Lab.
  • Developed Validation Protocols, Summary reports for Validating QC laboratory equipment.
  • Review and Approval of Intended Use, Validation Plan, Functional Requirement Specifications, System Configuration Specifications, System Design Specifications Documents, Installation Verification and Operational Testing, and Traceability Matrix.
  • Post-Execution review of the Installation Verification and Operational Testing Document, which consists of Installation Verification and Operational Testing Forms.
  • Installation Verification Forms capture System Identification, Documentation, Utilities and Environmental, Test Instruments Calibration, System Configuration Parameters, Hardware and Software Verification, Maintenance Program Spare Parts, and Process Instrumentation Calibration.
  • Operation Testing Forms captures testing of Operational Parameters Limits, 21 CFR Part 11, Alarm/Error Messages, Safety, Functional and Operational, Security, Loss of Utility, Data Backup and Restore, and Application Back up.
  • Validating Microsoft Excel Workbooks/Worksheets used in the Manufacturing Processes (COTS Configured)
  • Performing Gap Analysis for Assessing the Legacy System Validation Packages to Verify Whether or not the Systems was Adequately Validated to meet its Intended Use and Verifying whether the validation is planned according to the released Quality System Procedures and Work Instructions.

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