CAREER SUMMARY:

• Experienced and diverse Validation Analyst/ Quality Analyst with over 6 years of proficiency in validation protocols, technical writing, computer system/equipment validation, 21 CFR part 11, 58, 210, 211 and 820 compliance and Quality Assurance in FDA regulated environments.
• Extensive experience in Computer System Validation in compliance with FDA standards.
• Profound knowledge of Quality System Regulations for medical devices and pharmaceuticals such as, 21CFR Part 11, 21, 210, 211, 820, ISO 13485, 14971; cGXPs (GMP, GCP, GDP and GLP).
• Comprehensive knowledge related to 21 CFR Part 11: Electronic records, Electronic signatures and Audit trials.
• Hands on Experience in Trackwise for Initiating Change Controls.
• Expertise in Technical Writing and in Pre and Post QA Review of validation protocols like Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), Validation Master Plan (VMP) and SOP’s.
• Developed and analyzed test plans and test scripts to check functionalities of application of 21 CFR Part 11 compliance and FDA regulations, GAMP 4&5, cGXPs (cGMP, cGLP, cGDP).
• Successfully prepared and documented Validation Master Plans (VMP) and Validation Summary Reports (VSR).
• Proficiency in CAPA, Gap Analysis and Remediation plans to ensure compliance.
• Excellent working knowledge of Electronic Data Management System - Aegis, Laboratory information management systems-LIMS, Insight Publisher (electronic submissions), and Adverse Event Reporting System (AERS).
• Expertise in Writing Deviations and Resolutions generated for the system during the Executions/Installations of the Protocols for Lab Systems.
• Proficiency in validating, auditing and preparing SOPs for Pharmaceuticals and medical devices as per FDA regulations and providing corresponding user training
• Strong verbal and written skills for clearly delegating tasks to team numbers and for effectively communicating results to management

WORK EXPEREINCE:

Confidential, Coppell, Texas

Quality Validation Engineer

Responsibilities:

• Authored Requirements Traceability Matrix for Quality/R&D Lab Instruments including Chromeleon Ion Chromatography (IC), High Performance Liquid Chromatography (HPLC), FTIR, XRF, Bruker/ Rigaku XRD, Moisture Analyzers and weighing Analytical Balances.
• Involved in weekly meetings with the team.
• Authored IQ/OQ/PQ protocols for the various Lab Instruments including XRD, PSA, DensityMeter/Viscometer, FTIR’s.
• Hands on experience in writing Software Qualification (CSV) Protocols for various Lab Instruments.
• Authored User Requirements Specifications after discuss with Business and Stakeholders.
• Authored Test Scripts for various lab Instruments including X-Ray Diffractometer, Scanning Electron Microscope and Particle Size Analyzer.
• Authored Validation Summary Report for various Lab Instruments like X-Ray Diffractometer, Scanning Electron Microscope, IC, HPLC, Refrigerators, FTIR’s.
• Authored Admin SOP’s for SEM and XRD Systems.
• Authored detailed user friendly compliance reports of the documentation for the entire project in agreement to FDA standards.
• Participated in Change Control meetings with Change Review Board and proposed many change controls.
• Assisted EH&S officer to perform the safety assessment for Lab Instrument.
• Ensured Lab systems compliance with 21 CFR part 11 and GxP guidelines
• Participated in the Execution of the Spreadsheet Validation.
• Authored Deviations and Resolutions for the Lab systems occurred during the execution or the Installation of the protocol.
• Assisted in the execution of the Periodic Reviews for the Lab Systems for the QC Lab.
• Hands on experience with the master control.

Confidential, Groton, CT

Validation Engineer and Test Lead

Responsibilities:

• Authored Validation Plan and Verification Plan.
• Involved in daily meeting and status call with offshore Team.
• Hands on experience in writing Installation Qualification (IQ), Operation Qualification (OQ),
• Performance Qualification (PQ), User Requirement Specification (URS) and work instructions.
• Authored Test Plan and Test Cases for the Application in HPALM and involved in follow ups with BT and BTQA.
• Involved in Scrum meetings with all leads and Manager.
• Executed Test cases for the Application in HPALM.
• Pre-Approvals and Post-Approvals of User Acceptance Tests from compliance perspective and address the Test Problem Reports/Deviations during the execution.
• Involved in preparing Disaster Recovery Plan.
• Prepared Validation Strategy and Validation Approaches for the project.
• Authored for Validation Summary Report and Verification Summary Report.

Confidential, Dallas, TX

Validation Engineer

Responsibilities:

• Prepared Risk Assessment of the Scada System.
• Prepared ER/ Esig Assessment.
• Developed standards and templates for impact Assessment.
• Prepared Validation Master Plan according to GAMP5 guide.
• Involved in writing Validation Deliverables (IQ and OQ) for the SCADA System.
• Involved in preparing Disaster Recovery Plan.
• Prepared Validation Strategy and Validation Approaches for the project.
• Prepared detailed user friendly compliance reports of the documentation for the entire project in agreement to FDA standards.
• Authored for writing Test plan, Test Scripts and Test summaries.
• Involved in Preparing Validation Summary Report.
• Calibrated the equipment’s and documented the calibrations in compliance with cGLP
• Ensured compliance with 21 CFR part 11 and GxP guidelines.

Confidential, Gaithersburg, MD

Validation Analyst

Responsibilities:

• Produced and revised Computer System Validation (CSV) deliverables in compliance with GxP and FDA Compliance Regulations.
• Drafted and documented User Acceptance Testing Protocols (UATs), Operational Protocol (OQ) for several different modules in TrackWise
• Assisted testers during dry runs and upgraded protocols based on the results from the dry run.
• Reviewing and updating of Requirement Traceability Matrix (RTM) for different modules in TrackWise.
• Performed Functional Risk Assessment on new added requirements to figure out the level of risk and level of testing required for each new requirement.
• Prepared compliance report about the existing status of cGMP, cGCP and cGLP.
• Reviewed standard documents for validation deliverables like User Requirement Specifications (URS), Functional Requirement Specification (FRS)
• Drafted and documented Deviations during the formal execution of the OQ and UAT scripts.
• Administer and Support execution of the plans and report validation activities on (VSR) Validation summary reports.
• Reviewing of IQ, OQ and warranting that the documents are compliant with company specific GDPs
• Worked with Documentum for storing and retrieving documents
• Communicate risk and compliance issues regarding EDMS validation to Management.
• Prepared Validation Protocols (IQ, OQ, PQ), and Validation Final Report.
• Prepared Validation Plan after reviewing Functional Requirements of Electronic Document Management System (EDMS).
• Requirement Analysis of the application and performed GAP Analysis and created Remediation Plan based on GAP Analysis results.
• Reviewed the User Requirement and prepared the detailed Test Plans and Test Criteria.
• Good working knowledge of the entire Validation Life Cycle including development and execution of the entire QA process and responsible for developing and documentation of Test Cases and Test Scripts.
• Followed SDLC process with V-Model methodology for development and used Electronic Document Management System (EDMS) that included workflows for document reviews and approvals by regulatory and business teams.
• Reviewed and authored requirement documents including URS, SRS, Software Project Plan (SPP), Version Description Document (VDD), Installation Instructions, Software Verification and Validation Plan (VVP), Verification and Validation Summary (VVS) and Traceability Matrix.
• Developed test summary report, including test summary log, described the various validation activities performed during the Test Phase of SDLC.

Confidential, Foster City, CA

Validation Analyst/ Quality Analyst

Responsibilities:

• Validated computer systems and various in-house software applications according to FDA and cGxP regulations.
• Developed and implemented a complete software validation life cycle using V-model for installation of various in-house software applications.
• Drafted URS, Analyzed and prepared IQ/OQ/PQ Test Scripts to check if it has covered the functionalities, which need to be in compliance with 21 CFR Part11 rules set by FDA.
• Prepared detailed user friendly compliance reports of the documentation for the entire project in agreement to FDA standards.
• Conducted GAP analysis to identify compliance of 21 CFR PART 11 and formulated Remediation Plan.
• Made Deviation investigations, SOPs and Quality System Development.
• Generated the detailed reports of the bugs, pass-fail report and comparison chart.
• Defects were logged, tracked, reviewed and analyzed using Test Director.
• Documented the verified test result after executing the scripts.
• Worked with development team to ensure testing issues were resolved.
• Assisted in the maintenance of the CAPA.
• Worked closely with the Compliance and Validation Team Leader in this process.
• Conducted compliance audits and walk-downs and completed all the necessary follow-up reports

Confidential, Latham, NJ

Quality Analyst

Responsibilities:

• Validated various Process Systems like Fermenters, Filtration and Biochemical Reactors.
• Generated and revised SOP’s for all the Production, Quality Control/Assurance processes.
• Involved in determination of User requirements, Functional requirements and generating Conformance Standard Documents
• Reviewed and maintained detailed Standard Operating Procedures (SOPs) for authoring and exection of Installation Qualifications (IQs) and Operational Qualifications (OQs) protocols.
• Validated and involved in calibration of pharmaceutical instruments like HPLC, Spectrophotometer, Incubator and other analytical Instruments
• Involved in development of the Validation Master Plan for all equipments and procedures.
• Prepared and performed IQ, OQ and PQs for various analytical instruments such as HPLC, Spectrophotometer and Autoclaves.
• Determined Gaps in the current system and developed remediation pant to resolve it.
• Provided input and feedback to the QA team in the execution of the test plans and test cases.
• Maintained Requirements Traceability Matrix (RTM) to track requirements.
• Implemented and prepared validation summary report (VSR) and reported deviations and solutions.

Confidential, Bloomsburry, NJ

Validation Analyst/QA Analyst

Responsibilities:

• Authored installation SOP’s
• Prepared Validation Summary Reports (VSR)
• Prepared validation protocols - IQ’s, OQ’s, and PQ’s
• Performed GAP analysis to ensure compliance with GxP
• Helped in preparing Validation Master Plan (VMP) for AERS
• Involved in documentation of technical manuals, data flow diagrams, requirement documents etc.
• Involved in documentation of different stages of validation life cycle in compliance with 21 CFR Part 11
• Performed Data migration of legacy systems and ensured all the eCTD data are in compliance with the ICH (International Conference on Harmonization) Safety Guidance
• Developed Remediation Plan to bring the system in compliance with GxP
• Maintained Requirement Traceability Matrix (RTM) to keep track of user requirements
• Performed manual testing on system, before sending it to automated testing and updated reports on testing on Quality Centre
• Participated in Project meetings and reviews

Confidential

Validation Analyst

Responsibilities:

• Worked with validation lead to write Validation Master Plan(VMP)
• Wrote IQ, OQ,PQ and validation summary reports for production floor operations to comply with FDA and ISO regulations
• Involved in writing and reviewing SOPs for coaters, fillers and conveyors
• Reviewed and validated ladder logic programming in RS LOGIX 500 Software used for PLC based automation systems
• Reviewed and maintained design documents, diagrams and specifications for automation systems to comply with GDP.
• Involved in writing test cases and test scripts manual testing
• Performed GAP analysis to check compliance with cGxP
• Participated in Performance Qualification(PQ) of SCADA system
• Executed IQ and OQ for PLC/SCADA systems used for coaters, fillers and conveyors