PROFESSIONAL SUMMARY:

• Over seven years of experience as Validation Analyst, Quality Analyst and Technical Writer in the Pharmaceutical industry with emphasis on 21 CFR Part 11 and GXP regulations.
• Thorough experience with the Software Development Life Cycle (SDLC) approach and documenting validation deliverables.
• In depth knowledge of FDA regulations 21 CFR Part 11, 210,211 and participation in implementation of CFR Part 11 rules like Electronic Records, Electronic Signatures and Audit Trails.
• Experience with entire life cycle of Computer Systems Validation including User Requirements Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment and System Design Specifications (SDS).
• Strong experience in writing and executing IQ/OQ/PQ protocols, test scripts, test plans for Validation Testing.
• Strong experience and knowledge of GCP, GLP, GMP in pharmaceutical industry.
• Very proficient in writing, reviewing, revising and implementing Validation Deliverables
• Strong experience in Change Control Management System (CCMS) Laboratory Information Management System (LIMS), Enterprise Document Management System (EDMS) Adverse Events Reporting System (AERS).
• Excellent knowledge and experience in Good Document Practices (GDP)
• Specialized in automated testing using Mercury Quality Center.
• Good experience in performing manual testing methods like Integration Testing, Black box Testing, Functional Testing, Regression Testing, Backend Testing and also automated testing tools like Mercury Quality Center.
• Actively participated in audits for existing Validation documents and drafting an audit report and suggestions based on the best practices in the industry.
• Excellent Experience in performing Risk Assessments.
• Extensive experience in preparing Validation Summary Report (VSR) and Test Summary Report (TSR).
• Strong experience in preparing and reviewing Requirements Traceability Matrix (RTM).
• Very good understanding of Sarbanes Oxley Regulations.
• Good experience of performing Gap analysis and preparing Remediation Plan.
• Well versed in variety of Testing Methodologies and automated tools in QA field.
• Submitting testing reports for bug - reporting and bug-tracking using the Test Director.
• Excellent interpersonal, organizational, verbal and written communication skills.

TECHNICAL SKILLS:

Operating System: Windows2000/2003/XP/Vista/7/NT, MS-DOS

Languages: C, SQL

RDMS: MS Access, Oracle 8i/9i/10g, SQL Server 2000

Tools: MS Visio, MS Project, MS Office (Word, Excel, PowerPoint, Access), Documentum, Win Runner/ Load Runner/ Quick Test Pro

Bug Tracking and Reporting: Mercury Test Director, PVCS Tracker, Rational Requisite Pro, Clear Quest

Regulations: FDA Quality system regulations, 21 CFR (part 11, 50, 58, 210, 211), GxPs, IQ/ OQ/ PQ, LIMS, AERS, Audit trails

PROFESSIONAL EXPERIENCE

Confidential, IL

Validation Engineer

Responsibilities:

• Responsible for writing Validation Plan.
• Used Lab ware LIMS application, which has modules like sample testing, assigning new tests, entering results and reviewing result data.
• Used MS Visio to document workflow and flow diagrams for design business process. Used MS Project for planning and scheduling project activities.
• Documenting OQ and PQ test scripts for new functionality and modifying existing test scripts, execution and SOP development.
• Updated the Requirement Traceability Matrix (RTM) upon completion of Functional Verification and User Acceptance Test execution
• Interacted with Subject Matter Experts (SME) to understand and document the workflow and functionalities on different modules.
• Involved in project Management and Team building activities e.g. taking minutes of meeting and following up with team members to get the job done as discussed on time and scheduling other meeting as per project needs.
• Analyzed Test Scripts to check if it has covered all the functionalities.
• Retrospective Validation of Trial Finder. Involved in performing the GAP Analysis of the system. Developed Risk Assessment and Deviation Report
• Responsible for managing documents in the corporate document management system.
• Involved in developing Requirement Specification Document, System Requirement Specification, and Design Specification.
• Performed Computer System Validation Assessment for Labware LIMS system to identify the validation deliverables for the project implementation
• Managed lab data effectively and timely using SDMS
• Involved in creation of Master Test Plan to strategize the test approach in various test cycles.
• Involved in complete manual testing of the application by executing all the test cases and to check the functionality of the application.
• Managed and organized requirement coverage, Test Case Management and Defect Management using and communicating between Team Lead, Developers to resolve the technical issues.
• Conducted Installation Qualification and documented the test results, deviations and corrective actions.
• Conducted Functionality testing and Interface testing during the Operational Qualification.
• Performed the Back-End integration testing to ensure data consistency on front-end.
• Involved in executing test scripts and documented test results in Test Summary Report.
• Created Traceability Matrix to keep track of all the requirements and test scripts.
• Responsible for documentation of all aspects of the Computer System Validation Life Cycle deliverables in accordance with 21CFR Part11 and Good Laboratory Practices.
• Responsible for creating test cases for Installation and Operational Qualification (IQ/OQ) of the application.
• Used Test Director for bug tracking, reporting and following up with development team.

Confidential, NJ

Validation Engineer

Responsibilities:

• Review and approve validation documentation including Function Specification documents, Configuration documents, Operational and Performance Qualification Protocols (OQ and PQ), test cases, deviations and reports, and requirements traceability matrices. .
• Reviewed and approved post execution of OQ and PQ test cases and defects.
• Ensure documentation meets quality standards, applicable regulatory compliance and Confidential guidelines.
• Monitor and advise on quality of all deliverables and report to management.
• PQ test scenarios building and prelim work on traceability, to ensure all requirements are covered and tested.
• Manually Tested Functionality of Asset Accounting and its Account Determination
• Develop effective control and concepts by examining and evaluating business reports.
• Review requirements and specifications in medical device environment.
• Provide expertise in review of all deliverables across the project lifecycle.
• Ensure documentation meets quality standards, applicable regulatory compliance and Confidential guidelines.
• Review and approve Post execution of OQ test cases and defects.
• Track configuration changes, validate and approve the transports in the validated SAP client.

Confidential, West Haven, CT

Validation Engineer

Responsibilities:

• Responsible for developing Validation Plan, IQ/OQ/PQ protocols and Validation Summary Report.
• Utilized Documentum and created documentation in all phases of the SDLC
• 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 Confidential policies and procedures
• Developed Risk assessments and 21 CFR Part 11 assessments
• Expertise in developing and executing Installation, Operational and Performance Qualification (IQ, OQ and PQ) Validation Protocols.
• 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.
• Performed Periodic Reviews on regulated production computer systems
• Developed test plans, test strategies, test scripts for validation testing along with the Test Summary Report.
• 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.
• Responsible for writing Validation Summary Report to establish documented evidence that the system was validated according to the standards of 21 CFR Part 11.

Confidential

Validation Consultant

Responsibilities:

• Validated the Process used in making of Tablets.
• Generated a Process Validation Protocol
• Documented IQ(Installation Qualification) Protocol considering the following parameters; equipment manufacturer’s recommendations, electricity supply, reliability, Water supply, quality air pressure, quality Calibration of schedule & documentation, maintaining schedule, procedures, documentation, spare parts
• OQ(Operational Qualification) Protocol by establishing objective evidence process control limits and action levels which result in product that meets all predetermined requirements
• PQ(Performance Qualification) protocols by establishing objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements of the entire process
• Monitor and Control Process
• Also involved in Revalidation of the process.
• After Process Validation comes cleaning validation where in the machine was checked properly to avoid any contamination of other batches
• Worked with TOC (Total Organic Carbon) Analysis System used in Cleaning Validation.
• Responsibility for IQ and PQ of TOC system, whose data control system was very much compatible with 21 CFR part 11 comp
• Wrote Validation reports and submitting change controls

Confidential, Edison, NJ

Technical writer

Responsibilities:

• Worked on change control documentation such as Change Request Form (CRF’s), Change Control Implementation Plan, and Change Control Summary Report.
• Responsible for writing test plans, test scripts and executing them for validation testing.
• Reviewed and verified test results, identified and reported issues and provided summary test reports.
• Documented Installation Qualification (IQ), Operational Qualifications (OQ), and Performance Qualifications (PQ) documents using standard templates.
• Written and reviewed Requirement Traceability Matrix (RTM).
• Developed applicable test cases for integration test, system test and acceptance test. Defects are tracked while processing testing and reported using Test Director.
• Expert level knowledge in reviewing and modifying standard operating procedures (SOP).
• Reviewed and modified existing Standard Operating Systems (SOPs) for Document management system, System Administration, Change Control Procedures and Testing SOPs.
• Responsible for analyzing and reviewing validation deliverables like Validation Plan, User Requirement specification, Functional requirement Specification, System Design Specification document.

Confidential

Test Engineer

Responsibilities:

• Worked as a Manual QA Tester.
• Involved in testing on all stages of System Development Life Cycle
• Performed integration testing and build verification testing.
• Regression testing was implemented at various phases of the test cycles.
• Reported and tracked testing progress in the customized defect tracking system.
• Worked with developers to fix the defects.
• Involved in generating Test plan and test specifications as per user’s business Requirements.