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Validation Lead Analyst Resume

Warsaw, IN

SUMMARY

  • Experience as a Validation Analyst Technical Writer in Pharmaceutical environment with concentration in Computer System Validation (CSV), Equipment Validation with strict adherence to FDA regulations.
  • Professional Profile: Working experience in FDA regulated environment and pharmaceutical companies with good understanding of cGxP (cGMP, cGDP, cGLP) standards and Risk based validation.
  • Proficient in Business Requirement gathering, Project Management, Business Process Flow, Joint application design (JAD), Business Process Modeling and Business Analysis, Technical Documentation and RTM
  • Strong skills in creating Use Cases, Sequence Diagrams, Collaboration diagrams, Activity Diagrams, Class Diagrams and Test Cases.
  • In - depth understanding of System Development Life Cycle (SDLC), Unified Modeling Language (UML), Object Modeling Technique (OMT) and Object Oriented Analysis (OOA)
  • Writing reports based on Requirements Traceability Matrix.
  • Experience in creating Compliance deliverables like Validation Master Plan (VP), User/Business Requirements Specification (URS), Functional Requirement Specification (FRS), Design Specification (DS), Writing test scripts, Executing tests and Construction Summary Reports for Installation Qualifications (IQ), Operational Qualification (OQ) and Performance Qualification (PQ), Test Summary Report (TSR), Gap Analysis, Remediation Plans, Requirements Traceability Matrix (RTM) for validations in various pharmaceutical companies.
  • Strong understanding of 21 CFR Part 11, Quality System Regulations (QSR), cGMP, GxP (GMP, GLP, GCP), GAMP requirements including electronic records, electronic signatures, system validation strategies and documentation.
  • Extensive knowledge of Risk Analysis by identifying the vulnerability points and recommends Disaster Avoidance during and after installation.
  • Working knowledge of designing & implementation of all QA test strategy plans manually and using automated test solutions for client/server and web applications with HP ALM Quality Center, QTP (Automation & Testing) and manual testing.
  • Experience in conducting User Acceptance Testing (UAT), Smoke Testing, Regression Testing, Performance testing, and Functional Testing.
  • Working knowledge of JD Edwards, SharePoint, e-Room, Documentum, Trim Context Dataset on a regular basis for document storage and retrieval.

TECHNICAL SKILLS

Compliance: 21 CFR Part (11, 210, 211, 820, 56, 50), GAMP, cGMP, GxP (GMP, GLP, GCP), QSR, ISO9000, PMBok, ICH Guidelines.

Business Tools: MS Office, MS Project, WordPerfect, Outlook, Acrobat, MS VISIO, Share Point, Snipping Tool, Snag-IT, TrackWise7, CoBIT, RiskIT, ITIL software development.

Computer System Validation: SOP’S, VMP, URS, FRS, DS, IQ, OQ, PQ, Test protocols and Summary Reports, RTM, Audit Trails and VSR.

Methodologies: Software Development Life Cycle (Waterfall, Spiral, AGILE model, Agile Scrum)

Operating Systems: Window XP/2000/2003/XP/Vista, UNIX

Databases: Oracle MySQL, MS Access, SQL Server

Web Technologies: VB Script, XML, HL7, HTML, Perl, Java Script, Load Runner.

Medical Device Validation: QSR, ISO 13485, ISO 9001, ISO 10993, ISO

Validation Applications: LIMS, EDMS, AERS, EduNeering LMS, LIS, Siebel CRM, Oracle People Soft (Adverse events reporting systems), Oracle people Soft call center. EDHR.

PROFESSIONAL EXPERIENCE

Confidential, Warsaw IN

Validation Lead Analyst

Responsibilities:

  • Authored the various compliance deliverables such as Quality Plan, URS, FRS, DS and configurations workbooks for application based on the client business needs.
  • Determined the GxP risk assessments for the all the requirements for testing purposes.
  • Authored and developed quality templates to capture the appropriate information based on the new regulations and guidelines.
  • Review the documentation provided by the vendors such as User Requirements Specifications (URS), Infrastructure Requirements, System Requirements Specifications (SRS) and Design Specifications as per the client requests.
  • Adopted risk based validation approach for Testing according to the client SOP’s.
  • Classify the requirements into different categories such as Standard, configurations, Custom build, and report requirements for testing purposes.
  • Worked on writing Configuration IQ Test Cases, Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification scripts, System Requirement Specification (SRS) and Workflow diagrams for validation.
  • Take the responsibility to review and approval of documents from various team members and update the respective reviewed documents based on the feedback provided and re-route the documents for final approvals.
  • Coordinated various teams during executions to reach out to the testers and solve any issues.
  • Created and reviewed operational and architectural handbooks.
  • Documented Requirements Traceability Matrix (RTM) to track the requirements thru the Testing Phases.
  • Authored the Validation Summary Reports to capture the events that occurred in the projects.
  • Created Validation Summary Reports capturing all the events for the Go-Live purposes.
  • Worked on the different modules of LIMS including the Sample Management, Bath Management, Containers tracking, Stability Studies, Setup Studies, Study protocols, Stability conditions etc.
  • Worked on validation of Dionex IC which is an interface to the Empower 3.
  • Extensively performed RISK ANALYSIS by identifying the vulnerability points and recommended disaster avoidance.
  • Validated Empower with HPLC and UPLC systems using various reagents and pH Buffers.
  • Worked on validating and calibrating the HPLC and UPLC using the Empower 3.
  • Worked on drafting the Basic empower training course.
  • Worked on various lab instruments, integrating Empower-HPLC’s, GC-MS and Empower Data Acquisition software’s for the Automated GC and LC injection systems.
  • Worked on calibration and validation of laboratory equipment such as UV spectrophotometer, HPLC, dissolution apparatus, Disintegration apparatus.
  • Validated computerized laboratory equipment like atomic emission spectroscopy based on GAMP5.
  • Authored and Reviewed on compliance deliverables of the project including the Val Plan, URS/FRS, Configuration Specs, Design Docs for Integrations, FRA (GxP assessments, Validation Strategy, Risk Classification etc.), Test Cases creation and executions.
  • Involved in creation of Data Migration Strategy and Plan, which is an input for the migration of Legacy data into new LMS. (Data Verification and Validation)
  • Extensively worked with integration of LMS application with Salesforce.com, SAP HRIS, MES Camstar and OpenText.
  • Worked on Reports Design Documentation and used these designs for the validation of the various matrix reports.
  • Created RCA’s during the testing for the design and configuration changes from business.
  • Maintained and manages the team members from both onsite and off-shore.
  • Provide weekly updates to the team members and discuss the issues/Road Blocks and dependencies.

Confidential, Foster City, CA

Validation Analyst Lead

Responsibilities:

  • Gather Business Requirements: Focus on business requirements, pain points, and roadblocks; garter the information as requirements.
  • Created change requests workflows to monitor the changes for the projects adding accountability and value to the business.
  • Closely work with business to develop and understand the existing workflows, business process to create enhanced future workflows.
  • Document Business Requirements, Functional Requirements and develop relevant prototypes to help understand developers the requirements and business needs.
  • Developed As-Is process, To-be process, Business process mapping & impact assessments
  • Conducted Trend and impact analysis for risk remediation & mitigations based on business implications on IT maintenance and business use
  • Develop and maintain understanding of Business processes, systems and objectives.
  • To perform business analysis activities required to develop the benefits case for change or process improvement projects.

Confidential, Fort Worth, TX

Validation Analyst Lead

Responsibilities:

  • Reviewed the previous documentation for each module in the R&DLIMS application, and upgraded to the current template formats.
  • Worked on the MS Visio, to draw the workflow diagrams, Process flow diagrams for URS and FRS.
  • Maintained and ensured the accuracy of the requirements in URS and FRS by assigning the critical parameters to each of the user and functional requirements.
  • Documented User and Functional requirements on individual modules of R&D LIMS such as, Formulation Batch Modules (FBM), Stability Protocol Module (SPM), Integrated Stability Module, LIMS QA Module, Integrated Stability Update Module (ISUM), R&DLIMS Admin Module and Packaging Module(Labeling and Barcode)
  • Worked on Labeling System to generate barcodes to the finished products for tracking in Packaging Module.
  • Experience with Sample Manager and Packaging modules: Queried on the application to find out the different stability studies and generate various summary reports.
  • Participated in many project meetings providing the valuable inputs related to the regulatory requirements such as, Part 11 Electronic Records and Electronic Signature compliance, SOX compliance and importance of documentation, project deliverables, and validation deliverables.
  • Worked on reviewing High Level Classification Documentation (HLCD). Helped my teammates to understand the High Level Risk Assessments (HLRA’s) Document in conversion into new HLCD’s format.
  • Initiated the GAP analysis to identify the changes to be included in the current upgrade functionalities from the Control Change Request (CCR) log, Assigned tasks to work on Data Privacy, IT Security knowledge, Test Specifications (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.
  • Worked on the determining the custom requirements for e-Learning with LIMS for stability studies.
  • Worked on MS Project, to update the timelines and to schedule the project deliverables in a timely manner.
  • Helped our Project Manager in determining the project risks and calculated the risk occurrence and risk probability.
  • Created existing business workflows to examine the areas of improvements in the current flows.
  • After observations and analysis, I created To Be workflows, which are more efficient, and automated workflows to make sure the users can perform their day-to-day activities in more user friendly and efficient manner.
  • Worked with vendors and business units to felicitate the business process. (Vendor Assessments)
  • Conducted requirements gathering sessions and workshops.
  • Created compliance deliverables as per the FDA guidance for the GxP applications.

Confidential, Somerset, NJ

Validation Analyst / Tester

Responsibilities:

  • Involved in all phases of Computer System Validation (CSV) Life Cycle to comply with FDA regulations particularly 21 CFR Part 11.
  • Determined compliance of electronic records and electronic signatures with 21 CFR part 11 and also checked the management system protocols to be in compliance FDA Regulations GMP/QSRs, ISO 13485.
  • Involved in the complete life cycle from Planning, Organizing, Specification, System Assessment, Design, Construction, Acceptance Testing, IQ, OQ (Unit and Integration Tests), PQ, System Operation and Maintenance.
  • Worked on developing the User Requirements Specifications (URS), System Requirements Specifications (SRS) and Design Specifications as per the client requirements.
  • Developed High-Level classification documents (HLCD) based on risk assessments.
  • Worked on vendor assessment to verify the validation effort required for the client.
  • Suggested risk based validation approach for validating the configurations required by the client.
  • Performed deviation investigations and resolved issues by doing root-cause analysis and implemented CAPA, re-validation as necessary.
  • Worked on writing SAP-Operation Qualification (OQ) Specification, Performance Qualification (PQ) Specification scripts, SAP-System Requirement Specification (SRS) and Workflow diagrams for validation.
  • Coordinated various teams during executions to reach out to the testers and solve any issues.
  • Managed project timelines and keep track of all the team members and status updates.
  • Documented Requirements Traceability Matrix (RTM) to track the requirements.
  • Involved in performing Risk Assessment and proposed improvement suggestions on Validation processes.
  • Created Inventory logistics interfaces for SAP program for existing and new products utilizing process mapping and learn technologies.
  • Created, revised, and managed Laboratory Equipment documentation including User Requirements Standards, Design Qualifications, Trace Matrices, SAP Configuration Specifications and calibration documentation requirements.
  • Integrated LIMS with PI Data management services for MDM Project at enterprise level.
  • Communicated seamlessly and effectively and in a timely manner with Project Manager, Quality Assurance Validation, QC Technical Services (QCTS), QC Quality Control, Quality Engineering, Method validation team and multiple Catalent sites involved in Laboratory Equipment Qualification and Analytical Methods activities.
  • Developed Crystal Report templates for TrackWise and single / multiple reports for Adverse Events.
  • Served as BA for Regulatory Affairs Notification Lotus Notes Database, identifying business requirements, defining system scope and schedules, managing costs, and supervising four contractors; project successfully delivered within schedule and cost constraints.
  • Worked on data mapping and data migration using ETL tools. Validate the process and procedures for migrations.
  • Executed and wrote test scripts and validations, tracing ability matrix for TrackWise 7.0 and change control, audit manager, Material Tracker / Raw Materials Tracker, SOPs Tracker and training materials.
  • Completed patch upgrade 6.9 on time and within budget for all validated applications, including gap analyses with summaries.

Confidential, Fort Worth, TX

Validation Analyst

Responsibilities:

  • Reviewed the previous documentation for each module in the R&DLIMS application, and upgraded to the current template formats.
  • Worked on the MS Visio, to draw the workflow diagrams, Process flow diagrams for URS and FRS.
  • Maintained and ensured the accuracy of the requirements in URS and FRS by assigning the critical parameters to each of the user and functional requirements.
  • Documented User and Functional requirements on individual modules of R&D LIMS such as, Formulation Batch Modules (FBM), Stability Protocol Module (SPM), Integrated Stability Module, LIMS QA Module, Integrated Stability Update Module (ISUM), R&DLIMS Admin Module and Packaging Module (Labeling and Barcode)
  • Worked on Labeling System to generate barcodes to the finished products for tracking in Packaging Module.
  • Queried on the application to find out the different stability studies and generate various summary reports.
  • Participated in many project meetings providing the valuable inputs related to the regulatory requirements such as, Part 11 Electronic Records and Electronic Signature compliance, SOX compliance and importance of documentation, project deliverables, and validation deliverables.
  • Worked on reviewing High Level Classification Documentation (HLCD). Helped my teammates to understand the High Level Risk Assessments (HLRA’s) Document in conversion into new HLCD’s format.
  • Initiated the GAP analysis to identify the changes to be included in the current upgrade functionalities from the Control Change Request (CCR) log, Assigned tasks to work on Data Privacy, IT Security knowledge, Test Specifications (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.
  • Worked on the determining the custom requirements for e-Learning with LMS for stability studies.
  • Worked on MS Project, to update the timelines and to schedule the project deliverables in a timely manner.
  • Helped our Project Manager in determining the project risks and calculated the risk occurrence and risk probability.
  • Worked with the business & ETL to gathered requirements by Barnstorming and one-on-one questioner.
  • Co-ordinated with the supervisors and peers about regulatory requirements for the data handling, secure data collection and audit trails.
  • Researched and designed the entirely new business process flows and workflow assignments properly assigning them with the other parts of the instruments.
  • Worked on documenting the User and Functional requirements (URS and FRS), and addressed the conflicts from the reviewers in project meetings.
  • Assigned to work on other project deliverables, such as Equipment Qualification (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.
  • Drafted audit trails requirements in the URS and FRS for software for the future purpose.
  • Worked on MS VISIO and MS Project to document the project related deliverables.

Confidential, Indianapolis IN

Validation Analyst

Responsibilities:

  • Used MS Project for scheduling and planning project activities.
  • Documented and reviewed BRD’S and participated in designing Validation Master Plan (VMP).
  • Involved in creating FRS, TRS and other critical system documentation.
  • Validated the business, user and functional requirements and segregated them into Use Cases, context diagrams and activity diagrams using Visio, thus defining the Data Process Models.
  • Involved in validating SOPs with compliance to CFR Part 11, 210, and 211.
  • The governing activities include Authoring Templates for validation related documentation such as validation protocol and plans, IQ, OQ, and PQ.
  • Performed test designs, functionality testing, and regression testing on LIMS (Sample Manager) using HPQC.
  • Worked with IT and business teams to drive/maintain/create Quality program and align the design and development methodology with Validation plans, policies and procedures.
  • Developed documentation for all aspects of computer system validation including risk assessments.
  • Involved in performing GAP Analysis and documented the same to investigate gaps between system operation and the requirements of FDA regulations over the current system.
  • Responsible for authoring and reviewing Standard Operating Procedures (SOPs), URS/FRS, DS, Risk Assessment, IQ/OQ/PQ Protocols, Deviation Management, Traceability Matrix and Validation Summary Report.
  • Created compliance training sessions for users using the Cornerstone for Training Event Managements, Curriculum and Certification Management, reporting, training record management and for compliance.
  • Worked as a Packaging Engineer for generating the Serial Numbers and Barcodes in Labeling System for Finished Products and devices for medical use such as diagnostic equipment, surgical devices, ventilators and heart-lung machines.
  • Worked extensively with MS Office, MS VISIO, for authoring work flow diagrams in protocols like OQ and PQ. Created Manual Test Scripts and Qualify the Software.
  • Acted as Validation Proctor for guiding testers for formal execution of Scripts and provided suggestions on Deviation Reports.
  • Extensively performed RISK ANALYSIS by identifying the vulnerability points and recommended disaster avoidance.
  • Worked with RTM to track requirements and to co-relate with the executed test cases.

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