SUMMARY:

• Validation Analyst with over 7 years of work experience in Computer System Validation, Technical Writing, Data Analysis, Business analysis, Quality Assurance and noledge of FDA (21 CFR Part 11, 21 CFR Part 820) regulations and GxP (GMP, GLP and GCP) guidelines.
• Well experienced in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS).
• Experience in working on CDS (chromatography data system) and SDMS (scientific data management system).
• Used TrackWise tool for quality management issues and tracking applications for CAPA (Corrective and Preventive Action).
• Well capable of performing 21 CFR Part 11 Gap Analysis, Risk Analysis and developing Remediation Plans.
• Proficient with Excel to manage different testing and data segregation activities.
• Capable of preparing, reviewing and approving SOP's, Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ),Validation Master Plan (VMP),Validation Summary Report (VSR)and Requirement Traceability Matrix (RTM).
• Familiar with 21 CFR Part 11 drug cGxP requirements which include electronic records, electronic signatures, system validation strategies and documentation.
• Good experience in Software Development Life Cycle (SDLC), familiar with Waterfall, V-Model and Agile methodologies.
• Worked with Laboratory Information Management System (LIMS), Adverse Events Reporting Systems (AERS), Change Control Management System (CCMS) and Enterprise Document Management System (EDMS).
• Good experience in user acceptance testing (UAT), system testing, integration testing, regression testing, stress, load and performance testing.
• Skilled in using QTP, HP Quality Center, MS Visio and Documentum.
• Experience in developing documents like Test Scripts, Test Cases, Test Plans, Test design specifications, Test Procedures, Test requirements and testing standard
• Good noledge on Sarbanes Oxley Regulation (SOX), Sunshine act, Information Technology Infrastructure Library (IT-IL) guidelines.
• Good noledge of FDA Medical Device Reporting and international medical device regulations including 21 CFR parts 820.
• Extensive noledge of methods and process of medical device design control.

TECHNICAL SKILLS

Computer System Validation: 21 CFR Part 11 (210/211, 820), GAMP, cGMP, GDP, GLP, IQ, OQ, PQ, RTM, SOPs, Summary Reports, Audit Trails, Labware LIMSTrack: Wise, SAP ERP

Testing Tools: HP Quality Center, QTP

SDLC: Waterfall, V-Model, Agile

Business tools: MS Office (Word, Excel, Power Point, Access Visio), Argus Safety 6.0 and Documentum

Operating System: Windows XP/Vista/7/8/8.1, MS-DOS

PROFESSIONAL EXPERIENCE:

Confidential, NJ

Validation Analyst, TrackWise

Responsibilities:

• Involved in the Global Implementation and Validation of Global IT applications, CAPA, CCM Workflows.
• Reviewed and updated end to end validation documentation for Track wise (CAPA, CCM) to ensure compliance with company policies and procedures.
• Review and update validation deliverables Master Qualification Plan, GAP Analysis, Design and Architecture Document, Test Cases, Trace Matrix and Summary Report.
• Created and Reviewed several Change Controls for Quality validation plan, Risk Analysis Plan, IQ, OQ, PQ Protocols.
• Developed flowchart model of OQ workflows in MS Visio.
• Developed IQ, OQ, PQ protocols, Reviewed and executed them.
• Actively participated in the discussions during the configuration index and code review development.
• Attached electronic files as reference documents using TrackWise so dat they can be reviewed along with the overall request.
• Involved in periodic auditing of the change management systems to ensure dat the change management systems are in compliance with SOP.
• Wrote the OQ, PQ Test case Issues in the Test Track Pro and actively participated in discussion with the validation lead regarding the issues.
• Managed the overall protocol execution process including resource management, scheduling/timeline management, incident management, and status reporting.
• Reviewed and edited URS documents as per the changes requested by the users during the project.
• Created Risk assessment and Quality validation plan for the whole project.
• Developed/Maintained the Requirements Traceability Matrix (RTM).
• Performed Performance Qualification (Such as Load/Stress, Volume and Response Time) and User Acceptance Tests (UAT) and also documented them.
• Involved in the development of the Information Protection and Risk Management assessment.
• Reviewed and updated IQ/OQ/PQ Summary Reports, Validation Final Reports and Go Live memos.

Confidential, NJ

Validation Analyst, SAP ERP Validation

Responsibilities:

• Active role in validation of SAP ECC 6.0 upgrade and SAP Support Packs implementation and Web Applications in accordance with Company policies and procedures.
• Comprehensive noledge of GAMP 5 guidelines; GxP (cGMP, GCP, GLP) standards; 21 CFR Part 11, 820.
• Attended weekly status meetings with Team lead, Project Manager and Subject Matter Experts to update work progress.
• Involved in all phases of the computer systems validation lifecycle to comply with FDA regulations and GAMP 5 guidelines.
• Responsible for documentation of all aspects of the Computer System Validation Life Cycle in accordance with 21CFR Part11, GLP and GDP.
• Reviewed and Approved Test Scripts as a Quality Assurance in the Pre-Approval and Post-Approval Phases.
• Coordinated with users from Research & Development and Quality Control to gather requirements and drafted URS (User Requirement Specification).
• Involved in the execution of IQ/OQ protocol to complete the GAPS in vendor protocol and documented the deviations.
• Involved in the draft of Performance Qualification (PQ) protocol and proctored the execution of PQ by the user.
• Completed the draft and approval of Traceability Matrix and Validation Summary Report.
• Supported the assembly of the Functional and Design Requirements Specification documents.
• Assisted Business Analyst in the assessment and gathering of supporting documentation, such as Test Method SOPs, Material Specifications, Test Data Sheets and Reports, etc.
• Developed system-specific Standard Operating Procedures (SOPs) for the utilization of the ELN.
• Reviewed and completed training on the SOPs for ‘Spreadsheet Validation, use, and maintenance & Security.
• Co-ordinated with Developer for the development of spreadsheet as per the Design Requirements specified in SOP for validation of spreadsheets.
• Completed the draft of Traceability Matrix and Validation Summary Report. Routed the documents for approval.

Confidential, NJ

Validation Engineer/Medical Device Quality Engineer

Responsibilities:

• Customized and validated different components of the LIMS modules.
• Used Labware LIMS to perform various functions including logging in samples, assigning tests, preparing samples for analysis, assigning samples to analysts and instruments, recording results, the results approval process and reporting.
• Developed test scenarios for testing workflow paths in TrackWise.
• Managed implementation, validation support of Trackwise, to manage CAPA, Deviation, Change Control and Audit Management workflows.
• Acquired and documented the business requirements.
• Prepared Validation Master Plan (VMP) for validating LIMS.
• Assisted in documentation and development of SOP.
• Analyzed and reviewed Installation Qualification (IQ), Operation Qualification (OQ), Performance Qualification (PQ) protocols.
• Developed OQ and PQ test cases.
• Drafted IQ test cases for verifying configuration.
• Developed and reviewed test scripts and test cases for automated and regression testing.
• Executed the test cases stored in the Test Plan, imported locally to the Test Lab in HP Quality Center and reported the defects.
• Generated Validation Summary Report (VSR) to summarize and document all validation activities.
• Used Defect Management grid of Quality Center in logging and analyzing issues.
• Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11.
• Performed user acceptance testing (UAT) to the check the various functionalities of LIMS.
• Proficient with Corrective Action Preventive Action (CAPA) workflow including Investigation, Investigation Task, Action, Request, Request Extension and Closure phases.
• Conducted GAP analysis and prepared Remediation Plan.
• Responsible for ensuring the compliance of GMP/GLP and FDA regulations.
• Observed lab facility and implemented Quality systems for products in accordance to cGMP and ISO standards.
• Played a key role in developing techniques of quality engineering to test medical devices.

Confidential

Quality Assurance Executive/ Technical Writer

Responsibilities:

• Developed the Standard Operating procedures (SOPs) to enhance the quality of the services.
• Executed Quality Controls and Quality Assurance to improve the standards of the services.
• Executed Data analysis and studied the workflow of the process.
• Developed and implemented Quality plans for the process and involved in Audits and performed the quality check to verify the performance of the services.
• Used Test director to track and report the bugs.
• Investigated the process faults and interacted with the developers to fix the technical issues.
• Maintaining the database based on the feedback from the clients.
• Guiding the executives in improving the performance based on the one to one basis feedback.
• Responsible for preparing the Test Scripts using Test Director.

Confidential

Quality Control Analyst, Documentum

Responsibilities:

• Involved in verification, clarification and sign-off of the functional requirements/functional specification.
• Maintained all the logs and documents through a document management system Documentum.
• Followed the Standard Operating Procedure SOP’s for Document management system.
• Utilized Documentum for storage and retrieval of documents.
• Played a key role on project issues such as release management, change management, scope control, and requirements prioritization.
• Developed SOPs and Compiled Training Manuals for the new working environment.
• Documented strategy for maintaining the Validated State.
• Worked extensively with the QA team for designing Test Plan and develop the Test Scripts for the User Acceptance Testing.
• Communicated the daily operations of the validation team to the management and assured dat the master plans, protocols and reports are generated and approved within predetermined timelines.
• Validated the events and mechanisms dat can be used to initiate and perform the movement Event Triggers, Actions, Business Rules, Analysis Rules, Status Rules, Automation Scripts, Bar-codes, Schedulers and manual intervention.
• Submitted Final reports by Assisting documents dat can be queried by type of adverse events, disease and principle investigator.
• Performed positive and negative testing manually
• Prepared documents for reports dat can be queried by type of adverse event, disease and principle investigator.
• Reviewed and Documented IQ/OQ/PQ protocols