SUMMARY:

• 6 years of experience as a Computer Systems Validation, Quality Assurance, Quality Control and technical writing.
• Hands on experience in developing and documenting Validation Master Plan, Validation Summary Report VSR , Requirement Traceability Matrix RTM , Standard Operating Procedures SOPs and Work Instructions WIs .
• Extensive understanding and experience in validating the computer systems as per FDA regulations and cGXP GLP/GCP/GMP guidelines
• Extensive knowledge of FDA regulations 21CFR Part 11 Electronic Records, Electronic signatures and Audit Trails , 210, 211 820.
• Strong experience in implementing Good Documentation Practices GDP in writing and reviewing validation deliverables.
• Good understanding implementation knowledge of risk based Testing Practices GAMP5 guidelines .
• Proficient in reviewing and approving User Requirements Specifications URS , Functional Requirements Specification FRS , Design Specification DS , Test Plan and Test cases
• Intense knowledge of traceability matrices and exposure to Quality Control and Quality Assurance environment
• Excellent understanding of all phases of Software Development Life Cycle SDLC , Agile, Waterfall, V model, Spiral and Validation Life Cycle VLC .
• Reviewed and approved key validation deliverables and change management deliverables for computerized systems.
• Experience in validating Laboratory Information Management System LIMS , Adverse Event Reporting System AERS , and Chromatography Data System CDS .
• Experienced in performing Gap Analysis for 21 CFR Part 11 and remediation.
• Configuring and validation Laboratory Information Management System LIMS
• Experience in conducting Risk Analysis, Gap Analysis, and Corrective and Preventive Action CAPA .
• Experience in Track wise CAPA, change control , ECN, ECR, PDM, PLM tools.
• Experienced in difference types of testing End to End, Functional, Integration, GUI, Regression and UAT.
• Extensive experience with the operation and understanding of analytical equipment's like GC, HPLC, UV-VIS spectrophotometer.
• Good understanding of ICH Guidelines, OECD Principles, Sarbanes Oxley SOX , Process Validation, FMEA.
• Ability to manage multiple priorities in a fast paced environment.
• Good communication and Technical Writing Skills.

TECHNICAL SKILLS:

PROFESSIONAL EXPERIENCE:

Confidential

Role: Validation Engineer

Project Description:

• Validating Plateau Learning management system, Kofax capture Scanning software system as a remediation activity.
• Responsibilities:
• Developed IQ/OQ/PQ protocols related document management systems using EMC.
• Involved in configuring and validating Laboratory Information Management System LIMS for QC and Clinical Laboratories
• Involved in the documentation for protocols, Operation Qualification OQ and Performance Qualification PQ .
• Conducted Installation Qualification and documented the test results, deviations.
• Carried out GAP analysis and prepared Remediation Plan.
• Involved in gathering user requirements.
• Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification
• Assessed 21 CFR Part 11 Electronic Records, Electronic Signatures, audit Trails and Security events , Part 820, ISO 13485, ISO 14971.
• Validating the computer systems as per FDA regulations and cGXP GLP/GCP/GMP guidelines department with corrective action for the medical device.
• Conducted Functionality testing and Interface testing during the Operational Qualification.
• Validated systems by implementing Good Automated Manufacturing Practices GAMP-5 Developed Traceability Matrix to track the requirements during the QA Testing Phase.
• Involved in execution and review of test scripts and test cases.
• Facilitated Change Control processes related to application or system upgrades and bug fixes.
• Coordinated the validation activities with departments, while providing support services.
• Developed/Maintained the Requirements Traceability Matrix RTM , involved in UAT-testing.
• Developed WI/ SOP's for the systems and involved in training the users on them.

Confidential

Role: Validation Analyst/Document Control Specialist

Project Description:

• The scope of the project was to document the change request Forms CRF's , change control implementation Plan and change control Summary Report
• Responsibilities:
• Reviewed and modified existing Standard Operating Systems SOPs for Document management system and Testing SOPs
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document
• Worked on change control documentation such as Change Request Form CRF's , Change Control Implementation Plan, Change Control Summary Report
• Ensuring Change Controls are routed in a timely manner
• Organizing and maintaining records of Change Control
• Overseeing the Change Control administration system number assignment, typing, file maintenance, electronic file maintenance, and distribution
• Responsible for writing test plans, test scripts and executing them for validation testing.
• Documented Installation Qualification IQ , Operational Qualifications OQ , and Performance Qualifications PQ documents using standard templates
• Developed applicable test cases for integration testing, system testing and acceptance testing
• Reviewed and verified test results, identified and reported issues and provided summary test reports.
• Authored and reviewed Requirement Traceability Matrix RTM
• Tracked defects while testing and reported using HP QUALITY CENTER and manual testing.

Confidential

Role: Validation Engineer / Tester

Project Description:

The scope of the project was to validate Enterprise Document Management System EDMS . I have also assisted in developing Data Migration plans

Responsibilities:

• Developed Validation Master Plan
• Designed architectural diagrams, process map/workflow and entity relation maps of the documents or process using MS Visio
• Written User Requirements specifications, Functional Requirements specifications document, Design Specification document in compliance with 21 CFR PART 11 Requirements.
• Responsible for writing and executing Installation qualification IQ , Operational Qualification OQ and Performance Qualification PQ protocols to check installation and successful operation of the application.
• Performed front end testing, positive and negative testing, GUI testing, and regression testing
• Performed GAP Analysis and prepared Remediation Plans.
• Conducted reporting and tracking of defects using Quality Center.
• Utilized Documentum and created documentation in all phases of the SDLC
• Performed Risk analysis
• Created and maintained the Requirement Traceability Matrix RTM for the application.
• Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.
• Responsible for developing the Data Migration Plan.
• Involved in creating System operational and Administration SOP's.
• Executed test cases based on the test plan and in accordance with Good Documentation Practices GDP
• Responsible for reviewing and executing IQ/OQ/PQ test scripts.
• Responsible for performing User Acceptance Testing UAT for the application.
• Developed User manuals and Training manuals

Confidential

Role: Validation Tester

Project Description:

• The project involved validating the Inventory Management systems as per 21 CFR part 11, GMP and FDA regulations.
• Responsibilities:
• Reviewed previously available test scripts to get familiarize with the current Business system and its operation/process.
• Acted as a liaison between different levels of organization.
• Assisted in conducting initial Risk assessment.
• Maintained compliance with regulations GxP/Part11 , SOPs and Quality Management Systems.
• Conducted manual testing for Rockwell automated products
• Assisted in developing and reviewing Test Plan s .
• Facilitated system and user acceptance testing.
• Reviewed IQ/OQ/PQ, test plans and test scripts.
• Analyzed test script's to check whether all functionalities been covered in compliance with 21CFR part 11 requirements.
• Validated systems by implementing Good Automated Manufacturing Practices GAMP-5 Developed Traceability Matrix to track the requirements during the QA Testing Phase.
• Approved traceability matrices, deviation forms and validation summary reports VSR .
• Wrote Work Instructions and developed system change request.
• Created and reviewed Validation and Test Summary Reports.
• Assisted in conducting Gap analysis.
• Supported in Vendor/client audits.
• Root cause analysis and implementation of corrective action.
• Ensued that the Change control process is followed in compliance with change control SOP.
• Interacted with Subject Matter Experts SME to understand and document the workflow and functionalities on different modules.

Confidential

Role: QA Engineer

Responsibilities:

• Gathered and finalized Business Requirements and Functional Requirements for the project.
• Involved in creating flowcharts using MS VISIO to understand the flow of application and overview of the software system to be validated.
• Created Installation Qualification IQ , Operational Qualification OQ and Performance Qualification PQ protocols, and SOPs.
• Facilitated the implementation of the software to meet the requirements of 21 CFR Part 11.
• Developed Test Plan and Test Scripts verify application functionality.
• Involved in Regression Testing after bug fixing and changes in the application.
• Analyzed Test Scripts to be compliant with 21 CFR Part 11 to test the Audit Trail, Data Integrity and Data Security of the application.
• Performed GUI and Functionality Testing using Win Runner to ensure proper functioning of the application.
• Maintained Requirement Traceability Matrix RTM for the application.
• Involved in End to End Manual Testing of the application.
• Participated in meetings to discuss the issues of the applications and follow up with the developer.

Confidential

Role: Trainee Validation Engineer

Responsibilities:

• Coordinated with the project manager to write the Validation Master Plan.
• Participated in Writing the Test Plans and Test Protocols.
• Authored Test scripts for different projects.
• Assisted in developing Requirement Traceability Matrix RTM to track requirement during QA testing phase.
• Analyzed and documented detailed program information working and interfacing with software developers and members of various other dependent departments.
• Ensured the quality of systems in compliance with regulatory guidelines.