SUMMARY:

• Over 6 years of experience in Validation with strong background Computer System validation, Software Development Life Cycle, Technical writing along with performing Manual and Automated Testing in the Pharmaceutical environment with emphasis on 21 CFR Part 11,GXP (GMP, GLP, GDP and GCP) and SOX regulations.
• Experience in Pharmaceutical Environment with expertise in Computer System Validation (CSV), Equipment Validation, Technical Writing Testing and with strict adherence to GAMP & cGMP regulations
• Superior knowledge of GAMP, GxP’s (GCP, GLP and GMP), 21 - CFR Part 11 regulation of Electronic Records, Electronic Signatures and Audit Trails.
• Expertise in Software Development Life Cycle (SDLC), familiar with Waterfall, V-shape model and agile model.
• Good experience in preparing Computer System Validation Plan (CSVP)
• Skilled in developing Standard Operating Procedures (SOP’s), policies and working instructions to comply with FDA regulations.
• Experience in reviewing and developing User Requirement Specifications (URS) and Functional Requirement Specifications (FRS) in compliance and conformance with FDA rules and regulations.
• Comprehensive knowledge and extensive experience in technical writing of Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Validation Master Plan (VMP), SOP’s, Test Summary Report, Test Plans, Test scripts, and Requirement Traceability Matrix (RTM) in FDA regulated environments.
• Performed GAP analysis in identifying compliance gaps, developing corrective action and preventive plans, and implementing those corrective action plans.
• Good experience in writing Risk Assessment, Remediation Plan, Deviation report, and User Acceptance Testing (UAT).
• Proficient in dealing with Change Control Management System (CCMS), Laboratory Information Management System (LIMS), Enterprise Document Management System (EDMS)
• Experience in reviewing Corrective and Preventive Actions (CAPA) and highlighting and suggesting the remediation plans to mitigate the non-compliance.
• Extensively used Documentum for storage and retrieval of documents.
• Involved in Data Center Migration Project and responsible for developing the validation deliverables of Data center Migration Plan.
• Tracked and documented Change Requests using HP Quality Center.
• Experience in writing and developing Test Plans, Test Scripts, Test Procedures, and Test Summary Reports of all the laboratory equipment’s.
• Involved in writing the User Acceptance Test Summary Report.
• Proficient with Excel to manage different testing and data segregation activities.
• Expertise in Pre-Approval and Post-Approvals of Test Scripts.
• Used tools like Test Director for submitting testing reports for bug-reporting and bug-tracking.
• Expertise in automated testing tools such as Mercury Quality Center, HP Quality Center and experience in Quick Test Pro (QTP), and Load Runner.
• Good experience in performing testing methods like Load Testing Graphical User Interface Testing (GUI), Regression Testing, Integration Testing, Black box Testing, and User Acceptance Testing (UAT).
• Technically competent with MS Visio in developing flow charts and flow diagrams.
• Experience in handling Analytical instruments like GC, FTIR, HPLC, TGA, Mass Spectroscopy (MS), UV-Visible Spectrophotometer.
• Acquaintance in Method validation of almost all Analytical instruments

TECHNICAL SKILLS:

Validation skills: IQ/ OQ/ PQ, LIMS, Audit trails, Test Plan, URS, FRS, SOP’s, CAPA, Validation plan, RTM, Compliance Risk Profile.

Operating Systems: Windows 7/2000/2003/XP/Vista, MS-DOS.

Software: HP Quality System, MS Visio

Methodologies: Waterfall, V-Model, Spiral, and Agile

Compliance: FDA Quality system regulations, SOX, 21 CFR Part (11, 50, 58, 110, 210, 211, 600, 820), SOX, GxPs (GMP, GLP, GCP).

PROFESSIONAL EXPERIENCE:

Confidential, Irvine, CA

Validation Analyst

Responsibilities:

• Provided Quality Assurance support for migration of Datacenter.
• Created infrastructure-related documentation for the migration of applications in a server-based environment.
• Performed validation, Documentation, and setting the Quality Management Systems in place for regulatory compliance.
• Drafted Test Specifications (IQ, OQ, PQ) for DataCenter activities.
• Document, investigate and obtain resolutions for deviations obtained in IOPQs execution.
• Prepared Standard Operation Procedures (SOP’s) by adhering to FDA, cGMP standards and other appropriate regulations.
• Coordinate User Acceptance Testing and ensure successful closure of UAT
• Document Validation Summary report
• Provided Documentum Admin support following 21 CFR part 11.
• Initiation and processing of Change Control Requests through Documentum.
• Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Participated inValidationLife Cycle (VLC)planning, implementation and documentation
• Assisted in developingValidation Master Plan (VMP) and validated the process to comply with the FDA rules and 21 CFR Pat 11 regulations
• Worked on the MS Visio, to draw the 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.
• 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. .
• Initiated the GAP analysis to identify the changes to be included in the current upgrade functionalities from the Control Change Request (CCR) log.
• Approved Change Requests from Compliance prospective in ServiceNow.
• Executed IQ, OQ and PQ after every change implementations.
• Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP).
• Carried out Risk assessment to analyze and quantify different risk areas in the system.
• Involved throughout the testing and documentation phase of theSystemValidation project
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Executed Test scripts developed by other team members.
• Developed Test Summary Report (TSR) based on the execution of test scripts.
• Conducted User Acceptance Testing (UAT) to check the various functionalities and to make sure that all the user requirements are met and documented UAT summary reports.
• Analyzed Test Scripts to check if it has covered all the functionalities.
• Testing documentation development, review, pre-approval, execution, and post-approval of IQ, OQ, and PQ test scripts.
• Trained system users on Good Testing Practices and Good Documentation Practices.
• Responsible for designing scripts and executing Functional and Regression Testing.

Confidential, FL

Validation Analyst

Responsibilities:

• Involved in Risk Assessment of laboratory Instruments
• Involved in drafting and approval of URS for Laboratory equipments
• Responsible for creating the Corrective and Preventive Action Plan (CAPA) and performed the GAP analysis to remediate audit findings and observations given by the auditors for regulated Research and Development (R&D) applications
• Complete 21 CFR Part 11 compliance assessments of laboratory and manufacturing systems
• Validated computerized laboratory equipment based on GAMP 5
• Hands on experience in writing Requirement Traceability Matrix, SOP’s.
• Documented reports for installation qualification, operating qualification and performance qualification validation protocols (IQ, OQ, PQ) in agreement to FDA standards.
• Involved in preparation of documents for Computer systems validation documents in accordance to 21CFR Part 11.
• Maintained batch records to check the inventory tracking.
• Involved in good documentation practice of different stages of validation life cycle in compliance with 21 CFR Part 11
• Acquiring all the lab data electronically at its source and a full complement of instrument interfaces
• Responsible for Application Inventory Management and periodic review of the application logs
• Performed User Acceptance Testing (UAT) to the check the various functionalities of LIMS
• Involved in writing and executing test cases and test scripts to validate certain functionalities of LIMS.

Confidential, NC

Validation Tester/Technical Writer

Responsibilities:

• Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Reviewed the previous documentation for each module in the LIMS application, and upgraded to the current template formats.
• Participated inValidationLife Cycle (VLC)planning, implementation and documentation
• DevelopedValidation Master Plan (VMP) and validated the process to comply with the FDA rules and 21 CFR Pat 11 regulations
• Documented User and Functional requirements on individual modules of LIMS.
• 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.
• Worked closely with the Business Analyst to understand the business process.
• Queried on the application to find out the different stability studies and generate various summary reports.
• Assigned tasks to work on Test Specifications (IQ, OQ, PQ), Application Design Specifications and Operational Handbook.
• Executed the test cases usingQuality Center and documented results as part of IQs, OQs and PQs.
• Reported the defects in the execution of the test scripts to the developers using Defect Tracking Tools like Quality Center and updated bug report status
• Reported to the developers about updates and change defects in the execution of the test scripts and test cases using Quality Center.
• Prepared bug reports with detail instructions such as giving Defect Id, Description, Severity and Priority and generated reports to help developers in reproducing bugs.
• Participated in conference calls with the Business as well as Development participants for discussing results, decision-making and planning of the testing processes.
• 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 MS Project, to update the timelines and to schedule the project deliverables in a timely manner.
• Initiated the GAP analysis to identify the changes to be included in the current upgrade functionalities from the Control Change Request (CCR) log.
• Helped our Project Manager in determining the project risks and calculated the risk occurrence and risk probability.
• Implemented Change Proposals and Change controls.
• Executed IQ, OQ and PQ after every change implementations
• Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP).
• Carried out Risk assessment to analyze and quantify different risk areas in the system.
• Involved throughout the testing and documentation phase of theSystemValidation project
• Helped conducting vendor assessments - reviewed quality policies and testing practices.
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Executed Test scripts developed by other team members.
• Developed Test Summary Report (TSR) based on the execution of test scripts.
• Conducted User Acceptance Testing (UAT) to check the various functionalities and to make sure that all the user requirements are met and documented UAT summary reports.
• Analyzed Test Scripts to check if it has covered all the functionalities.
• Reviewed test cases and scripts and documented the results as per the FDA regulations.
• Testing documentation development, review, pre-approval, execution, and post-approval of IQ, OQ, and PQ test scripts.
• Co-ordinated system users on Good Testing Practices and Good Documentation Practices.
• Responsible for designing scripts and executing Functional and Regression Testing.
• Responsible for manually testing the samples results and validating reports generated by the application.

Confidential

Technical Writer/Validation Tester

Responsibilities:

• Reviewed and modified existing Standard Operating Systems (SOPs) for System Use SOPs. Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
• Experience in using TOC (Total Organic Carbon) Analysis System.
• Wrote training manual and SOP’s.
• Participated in quality aspects of analyzing and reviewing validation deliverables like Validation Plan document, User Requirement document, Functional Specification document, and System Design Specification document and are in compliance with GMP and 21 CFR Part 11.
• Developed IQ/OQ protocols against User specifications and Functional specifications.
• Prepared the test Cases by going through the Design, Functional Requirements, and User requirements.
• Involved in writing Validation Summary Report (VSR) and archived all documents to make sure they were in compliance with 21CFR Part 11 regulations.
• Involved in writing and reviewing Requirement Traceability Matrix to track User and Functional Requirements.
• Traced RTM (Requirement Traceability Matrix) to identify affected system components when there is a required change.
• Responsible for writing test plans, test scripts.
• Reviewed and verified test results, identified and reported issues and provided test summary reports.