Summary

More than 6 years of experience as Validation Engineering with extensive experience in FDA 21 CFR Part 11, CFR 211/210 validation, performing Gap analysis, Remediation Plan, SOPs, Validation Protocols, Technical Writing, Quality Assurance, Automated Test Tools and Test cases and Corrective and Preventive Actions CAPA .

Expertise

• Hands on experience in writing documentation for all aspects of the software development lifecycle SDLC and Quality Assurance methods like Installation Qualification IQ , Operation Qualification OQ , Performance Qualification PQ and final validation reports.
• Expertise in developing User Requirement Specifications URS , Functional Requirement Specifications FRS , Design Specifications DS of all the computerized systems and Laboratory instrumentation.
• Strong knowledge and background of Software Development Life Cycle SDLC and Validation Life Cycle VLC . Familiar with Waterfall, Agile, Spiral and V-model.
• Wrote OQ, PQ documents and Performed certified validations for CPR
• Worked as ERP consultant and Installed, configured ERP application
• Experience with Laboratory Information Management System LIMS like Watson LIMS SQL LIMS environments.
• Extensive experience with reviewing and developing test cases and test procedures for the LIMS application
• Designed and Implemented the Validation Master Plan.
• Good knowledge of cGMP, cGCP and cGLP validation practices.
• Excellent experience as a Technical Writer under the FDA rules and regulations.
• Performed the Gap Analysis and Remediation plan according to the 21 CFR Part 11.
• Analyzed Test Scripts to ensure compliance with 21 CFR part 11 with respect to Audit Trail, Data Integrity and Data Security of the application
• Ensured Calibration of all laboratory equipments like GC, HPLC, Autoclaves, Ovens, Incubators, ICP Mass Spectrophotometer and wrote SOPs for calibration and maintenance of these equipments
• Documented new Standard operating procedures and reviewed the current operating procedures.
• Skilled in preparing the Requirement Traceability Matrix document.
• Experience working with Document management system Documentum , Trackwise.
• Experience in reviewing, modifying and writing standard operating procedures SOPs and validation plans
• Sound knowledge in software application validation, user acceptance testing and process documentation
• Sound knowledge of clinical trial processes, clinical data management practices and computer programming
• Skilled in analysis, design, specification and programming of computer systems
• Ability to perform programming, debugging, data analysis and system analysis

Technical Skills:

Project Experience:

Confidential

Validation Engineer

Responsibilities:

• Designed, Developed and Managed the QA process based functional requirements.
• Coordinated with the Senior Validation Engineer to write the Validation Master Plan.
• Developed and executed validation guidelines for testing the cGMP sensitive transactions.
• Developed Requirement Traceability Matrix RTM to track requirement during QA testing phase.
• Coordinated with Systems Analyst and Network Administrator to make the server and machines qualify through complete Installation Qualification IQ and Operational Qualification OQ procedures.
• Performed Manual Testing of the application prior to Automated testing using WinRunner.
• Performed GAP Analysis.
• Used LoadRunner to perform Performance and Stress testing.
• Used TestDirector for bug tracking and reporting, also followed up with the development team to verify bug fixes and updated bug status.

Confidential

Validation Engineer/Technical Writer

Confidential is one of the world's leading multi-specialty healthcare companies which focuses on discovering, developing and commercializing pharmaceuticals, and medical devices in the fields of ophthalmology, neurosciences, medical dermatology, gastroenterology and urological diseases. As a member of the team the objective was to validate equipment and chromatography data software using SDLC.

Responsibilities:

• Analyzed and documented Business Requirements and developed Master Test Plan
• Validated computer systems according to FDA regulations
• Developed and followed SOPs that were in accordance with GAMP regulations and also trained the required users
• Wrote IQ/OQ/PQ Qualification protocols to validate laboratory instruments, equipments and associated computerized systems e.g. High Pressure Liquid Chromatograph, Gas Chromatograph, Atomic Absorption Spectroscopy, Ultra Violet Spectroscopy, Karl Fisher, Incubators, Water Systems .
• Involved in developing and executing Installation Qualification IQ , Operation Qualification OQ , Performance Qualification PQ for equipments such as Chromatography systems, Incubators, Spectrophotometers, Autoclaves
• Review and approve pre-executed and post-executed Installation/Operational/Performance Qualification Protocols.
• Review Instrument and equipment related Work Instructions for quality and compliance issues communicate any identified potential problems to supervisors.
• Review change control documentation for applicability to company standards.
• Conducted Testing for functionalities of the Chromatography data software that was used for Hewlett Packard 1100 high performance liquid chromatography HPLC and analyzed results to ensure compliance with 21 CFR PART 11 with respect to Audit Trails, Data Integrity and Data Security of the application.
• Conducted GAP analysis to identify compliance of 21 CFR PART 11 and formulated Remediation Planning
• Prepared Validation Summary Report VSR
• Customized and validated LIMS modules and performed Data Migration

Confidential

Validation Analyst

Project: Confidential is the premier pharmaceutical company. Worked on the clinical Trial Information System, which is developed to maintain a data repository of the records pertaining to the clinical trials performed by the Tyco Healthcare

Responsibilities:

• Developed Validation Test plans according to IEEE standards and in conjunction with FDA regulations.
• Assured that all validation documentation such as IQ's, OQ's and PQ's are in compliance with cGMP's 21 CFR Part 210/211 .
• Involved in complete manual testing of the application.
• Involved in Equipment Qualification for lab instruments like UV-Visible Spectrophotometers, Autoclaves, Particle Analyzers, and Plate Readers.
• Prepared planning and execution of Validation Master Plan VMP , specifying requirements URS/ FRS , creating protocols - Installation Qualification IQ , Operational Qualification OQ and Performance Qualification PQ , creating Traceability Matrix, and writing Validation Summary Report VSR for equipment validations in accordance with FDA regulations, particularly 21 CFR.
• Performed System validation before the commencement of the Validation process.
• Tracked the validation progress through Validation Assessment Reports.
• Checked whether the executions of e-sigs are audit trailed.
• Tested for signature manifestations in compliance with 21 CFR Part 11.
• Followed CFR PART 11.10 extensively testing the e-sigs
• Developed TMV protocols and Cleaning validation reports
• Prepared Requirement Traceability Matrix RTM .
• Base line the Test plan, Test Criteria Project Schedule by walkthroughs and reported the defects created by QA Testers to the Developers using the HP Quality Center
• Drafted new SOPs and trained users on these systems and the implications and impact of 21 CFR 11 compliant data systems on day-to-day functions

Responsibilities:

• Conducted operational testing of LabWare LIMS software and involved in writing of Operational Qualification of various LIMS modules.
• Involved in developing, executing and documenting SOPs, Test Plans and Test Scripts.
• Developed Traceability Matrix matching URS and UAT for LabWare LIMS.
• Involved with the risk management team in implementing a risk based validation system for EDMS and LIMS using GAMP 5 guidelines
• Involved in making the system compliant to GAMP regulatory requirements.
• Executed OQ and PQ test scripts and generated test summary reports.
• Interacted with the lead user and wrote PQ scripts and was responsible for User Acceptance Testing UAT .
• Used Quality Center to organize defect reporting and bug tracking procedures for both functional and regression test

Confidential

Validation Engineer

Responsibilities:

• Worked in concurrence to FDA and cGXP regulations for the entire application
• Developed IQ, OQ, PQ for equipments including chromatography HPLC and GC and other analytical laboratory instruments like plate readers and liquid particle counters
• Responsible for determining the System Risk Assessment SRA and Functional Risk Assessment FRA for the instruments in accordance with GLP and part 11 regulations
• Prepared and maintained accurate documentation of clinical database structures, database patterns and data validation specifications
• Implemented, managed and maintained a global Electronic Data Capture EDC solution for clinical studies
• Interacted with clinical project managers, clinical staff and statisticians to provide support for database activities
• Assisted in validating electronic systems and programs according to existing regulatory necessities.
• Provided Clinical Data Management, Clinical and Statistical Programming, Biostatistics and Clinical Research functions
• Responsible for documenting the User Requirements, Validation Plan, Validation Summary Report, Traceability matrix and Performance Qualification test cases for the lab instruments
• Coordinated with the vendor and assessed the validation package IQ, OQ, PQ
• Coordinated with the business users and team members in updating Standard Operating Procedures for lab equipments
• Involved in conducting GAP analysis, authoring deviation reports and setting up of a Remediation Plan
• Developed, organized and managed multiple tasks with effective time management

Responsibilities:

• Developed TMV protocols and reports for routine methods used in the laboratory.
• Perform cleaning validations on reprocessed single-use medical devices, testing for the presence of residuals through protein, carbohydrate, and total organic carbon assays.
• Analytical test validations, IQ/OQ/PQ protocols and reports.
• Performed Environmental monitoring viable and non-viable in controlled environments as well as ISO classified clean rooms
• Performed Quality control of purchased media, reagents, and other test supplies
• Daily Bioburdens on finished and in-process product
• Checked-in incoming raw materials according to material requirements.
• Maintained and monitored the microbial counts present in the manufacturing and clean rooms.
• Physical testing of all products according to quality procedures, making sure products meet their given product specifications before being released.

Confidential

Technical Writer

Responsibilities:

• Gathered User requirements and developed User and Functional Requirement Specifications URS
• Documented IQ, OQ, and PQ for different modules of Laboratory Information Management System LIMS , Applied Biosystems SQL LIMS using Documentum
• Coordinating with the quality assurance team in developing SOP's including change control procedures and trained users on SOP's
• Authored training materials and conducted training sessions for system testers and end users
• Conducted User Acceptance Testing UAT and documented UAT Summary reports
• Developed and maintained Validation Master Plan
• Preparing Standard Operating Procedures SOPs , Installation Qualification IQ , Operational Qualification OQ and Performance Qualification PQ laboratory equipments like Spectrophotometer, Chromatography GC HPLC , Incubator, Autoclaves and other analytical instruments
• Quoted and preserved Remediation Plans for the gaps found during development
• Updated and maintained Requirements Traceability Matrix RTM
• Extensively used Documentum for storage and retrieval of documents.
• Worked under tight timelines with support of team members and supervisor

Confidential

Validation Engineer

Responsibilities:

• Designed and Developed the Validation Master Plan.
• Involved in the entire Validation Life Cycle.
• Worked on the Installation Qualification IQ Specification, Operation Qualification OQ Specification, and Performance Qualification PQ Specification.
• Performed manual testing on most of the GUI interfaces of Watson LIMS.
• Actively participated in developing test procedures and test cases to perform manual testing on Watson LIMS.
• Assisted in preparing the Validation Report using the Advance Reporting tool incorporated in the Watson LIMS package.
• Reviewed the business requirements and the existing test cases and product requirements.
• Validated the Watson LIMS against FDA 21 CFR 11 rules.
• Created and executed test cases for new TrackWise modules Internal and External Audits .
• Implemented cGLP and cGMP during the testing.
• Experience working with Document management system Documentum .