SUMMARY

• Having 7+ years of experience in Validation Methodologies, Medical Devices, Quality Assurance, Quality Control and Technical writing in Pharmaceutical/ medical device Industry with a strong background in performing Computer System Validation and Software Development
• 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)
• Experience with entire life cycle of Computer Systems Validation including User Requirements Specifications (URS), Functional Requirements Specifications (FRS) Vendor Assessment (VA) and System Design Specifications (SDS).
• Experience in validation of Quality systems like Application Server, Disaster Recovery system, Back Up Server, Supplier Audit Database and Controlled Spread sheet.
• In depth knowledge of FDA regulations 21 CFR Part 11 and 21 CFR Part 820
• Good expertise in developing, executing and reviewing IQ/OQ/PQ test scripts, Risk Assessments, Regulatory Assessments, Gap Analysis and CAPA (Corrective Action And Preventive Action) Documents and Failure Mode Effect Analysis (FMEA)
• Experience in quality management system (QMS) but not limited to ISO 13485, ISO 14971.
• Ensuring that the clinical and medical device documents are in compliance with cGMP and GLP guidelines.
• Knowledge on writing quality process requirements and performing GAP analysis to meet the requirements
• Developed Comprehensive Test cases and Test Summary Reports.
• Participated in laboratory proficiency - testing, monitoring testing procedures to ensure that all tests are performed according to the standard test methods or protocols, and ensuring the established specifications are met.
• Experience working with bug reporting tool HP Quality center
• Knowledge of design history files and design history file deliverables.
• Developed comprehensive Test Plans, Test scripts, Test Case and Test Reports and performed UAT(user acceptance testing) testing using HP Quality Center and manual testing
• Good Knowledge of testing methodologies, strategies and Software Development Life Cycle (SDLC) methodologies such as Water Fall, Agile and V model
• Hands on experience with GAMP 5 Guidelines.
• Experience working with Adverse Event Reporting System (AERS)
• Expertise in using documentation tools like MS WORD, MS Excel, MS Power Point and MS VISIO
• Excellent experience in validating wide variety of applications and infrastructure - Argus Safety, SAP, Excel spreadsheets, Electronic Document Management System (EDMS Documentum), LIMS, and AERS, eCTDXPress, Documentum.
• Sound Knowledge in working with Change Control Management Systems (CCMS), phases of Research & development cycle.
• Expertise in handling various analytical instruments like HPLC, TLC, LC, GC column chromatography, UV-Visible Spectrophotometers and flame photometer
• Expert in using Quality Center for managing tests and defects.
• Experience in Validation Procedures, technical writing for systems in compliance with cGMP, GAMP,/GAMP5, cGLP, and cGCPs.
• Experience in writing and reviewing Computer System Validation Plan/Remediation
• Excellent Coordination skills, Communication Skills and strong Technical Writing skills and a good team player.
• Possess solid analytical thinking, problem solving skill and positive attitude

TECHNICAL SKILLS

Computer system Validation: 21 CFR Part 11, 210, 820, GxP (cGMP, GCP, GLP), SOPs, GAMP, Summary Reports, Audit trails

Methodologies: Agile, Waterfall and V-model

Applications: Argus Safety, AERS, Documentum, LIMS and Trackwise, eCTDXPress

Technical Writing: Validation Master Plan (VMP), Functional Specification (FS), Design Documents (DS), Test Plans, Requirement Traceability Matrix (RTM), Test Cases, Text Summaries, GxP Compliance Report Generation, Software Generation

Bug Reporting Tools: HP Quality Center

PROFESSIONAL EXPERIENCE

Confidential, Piscataway, NJ

Sr. Validation Engineer

Responsibilities:

• Performed User and Business Requirements analysis to prepare Validation Master Plan
• Established operating requirements and conducted tests to assure it is operating under normal and worst case
• Performed Integration, Positive and Negative Testing of the application
• Reviewed IQs, OQs, and PQs and documented results in compliance with FDA regulations
• Performed GAP Analysis and developed Remediation Plans
• Performed System testing and documented results as part of IQs, OQs and PQs
• Updated and Maintained Required Traceability Matrix (RTM) as per the changing requirements
• Involved inDefect tracking,reviewingandanalyzing and reporting test result using HPQuality Center
• Spreadsheet validation of data for the QA testing of raw materials and finished products for non-conformity for suppliers scores cards, supplier’s management.
• Identifies, plans, recommends, and completes assignments leading towards profound process and product understanding of significant importance.
• The project also involves preparing the Validation Summary Report that summarizes the validation activities that were performed for the LIMS application.
• Conducted remediation for the verification and validation results in order to make sure all the evidences are recorded and stored according to the Good Documentation practices.
• Involved in performing CAPA procedure report non-conformities and reporting the deviations and documenting them.
• Documentation according to QMS for internal audit

Confidential, Chalfont, PA

Sr. Validation Tester

Responsibilities:

• Involved in Implementation and Validation of E-Submissions system eCTDXPress Project.
• Responsible for developing Validation 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.
• Reviewed and updated end to end validation documentation for Track wise to ensure compliance with company policies and procedures.
• Hands on review of the following deliverables - Regulatory Assessments, Risk Assessments, Validation Master Plans, Qualification Protocols, Design Reviews, User/Functional Specifications, IQ/OQ/PQ, Validation Summary Reports, Final Reports, Gap Analysis/Remediation Plans, User Manuals and Training Materials.
• Developed OQ and PQ test cases for Track wise
• Coordinated the execution of Operational Qualifications Test Scripts with different modules and specifications.
• Assisted in documentation and development of SOPs for Track wise application.
• Conducted Regression testing and run the scripts in validated environment for performance of the application
• Wrote IQ, OQ and PQ and developed Data migration protocols and conducted the dry run in Quality Center.
• Developed Detailed Risk Assessment documentation for managing the risk levels used before validating the system.
• Developed and maintained Trace Matrix document for mapping the URS, FS, DS (Design Specification), IQ, OQ and PQ
• Developed test scenarios for testing workflow paths in Track wise.
• Performed risk analysis activities to support non-conformances,QualityInvestigations, Product Impact Assessments, Product Risk Evaluations and CAPA(corrective action and preventive action) investigations, root cause analysis
• 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.
• Responsible for developing the Data Migration Plan
• Involved in creating System operational and Administration SOP’s
• Performed review of Device History Records and other documentation for compliance to established procedures and Good Documentation Practices
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.

Confidential, Hudson, NH

Validation Analyst/Tester

Responsibilities:

• Performed design verification pertaining to device QMS ISO 13485, 14971 for risk management, QSR 820
• Maintained the laboratory in accordance to established cGMP, GLP, & 5S industry standards, conducted monthly audits of laboratory procedures and testing/product flow processes in order to identify potential areas needing focused improvements, and participated in internal and FDA audits as required.
• Utilized Documentum and created documentation in all phases of the SDLC.
• Performed Risk analysis
• Developed the Functional Requirements Specification of LIMS by interacting with business users and development team and by using User Requirements Specification document.
• Developed the Validation Plan (VP) for SAP implementation by following the corporate guidelines.
• Collected User Requirements (URS) for Trackwise by interacting with the users and developed Design Specification (DS) for conformance with 21 CFR Part 11 based on the requirements.
• Developed Master Test Plan to strategize the testing approach to test SAP modules to meet the requirements defined in FRS.
• Close interaction with designers and software developers to understand application functionality and navigational flow.
• Created the strategy document that defines the LIMS test environment, phases of testing, entrance and exit criteria into different phases of testing and resources required conducting the effort.
• Identified necessary internal and external resources for completion of successful validation projects comprising of updating specification, purchasing and validating equipment and amending documents due to design change of a diagnostic device.
• Followed good test practices to document the test evidence (Screen Prints), Deviations, Resolutions, and Corrective Actions.
• Developed the Test Execution Guidelines to train the business users to execute the scripts as part of UAT.
• Developed the test scripts to test the Security User Profiles and Audit Trail to meet the Part 11 regulations.
• Performed and implemented technical and peer reviews of product documentation
• Performed Design of Experiments (DoE) using Minitab and analyzed various process parameters with the use of statistical tools (SPC) such as Gage R & R, Gage linearity and Bias study, interaction plot, process capability study to optimize the blending and compression process.

Confidential

Validation Engineer / Tester

Responsibilities:

• Developed cGMP related quality system requirements
• Involved in development activities including preparation of System Design Specification (SDS).
• Prepared documentation for all aspects of the Computer Systems Validation (CSV) lifecycle, in accordance with FDA regulations including 21 CFR Part 11, GMP and GLP.
• Worked closely with users and the vendor to understand and document user requirements, and functional design specifications.
• Involved in validation of Siebel system application including preparation of protocols.
• Involved in writing Installation and Operational Qualification Test Scripts and Test Plans.
• Performed Build Verification, Positive, Negative and Boundary, Functional, Integration, System and Regression Testing.
• Performed Performance Qualification (Such as Load/Stress, Volume and Response Time) and User Acceptance Tests (UAT) and also documented them.
• Performed Global adverse effect case data management and regulatory reporting to the industry using Argus safety
• Wrote the Standard Operating Procedures (SOP’s) for LMS by following the departmental and company SOP’s.
• Developed and reviewed Traceability Matrix (TM).
• Verified the operation capabilities of the process in the prescribed operation range.
• Developed and reviewed GxP computerized system documents including those related to system performance, compliance evaluation and validation.
• Participated in various meetings and discussed Enhancement and Modification Request issues

Confidential

Validation Analyst/Technical Writer

Responsibilities:

• Documented and reviewed BRD’S and participated in designing Validation Master Plan (VMP).
• 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.
• Performed test designs, functionality testing, and regression testing on LIMS using HPQC.
• Documentation maintenance according to QMS regulation for calibration, internal audit by spreadsheet data validation
• 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.
• Extensively performed RISK ANALYSIS by identifying the vulnerability points and recommended disaster avoidance.
• 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.
• Worked on Load Runner for Performance testing (Including stress testing, Measuring speed, Stability, Scalability, Server)
• Acted as Validation Proctor for guiding testers for formal execution of Scripts and provided suggestions on Deviation Reports.
• Worked on LMS (Learning Management Systems) customizing functionality like registration & administration, Training Event Managements, Curriculum and Certification Management, reporting, training record management, and courseware review.
• Executed protocols to prevent overlaps, contradictions, and disconnects in documents
• Created, maintained, summarized, reviewed, and approved QA related-documentation against quality-document attributes