Summary

• Seven years of experience in Biotech/Pharmaceutical companies with emphasis on manufacturing, Computer System Validation, Equipment Validation, Technical Writing, and Software Quality Assurance.
• Working experience in computer system validation experience in compliance with FDA regulations, including Laboratory Information Management System LIMS , Scientific Data Management System SDMS and Adverse Event Reporting System AERS .
• Excellent understanding of cGXP cGMP, cGLP, cGCP standards and their practices
• Experience with aspects of 21 CFR Part 11 mainly on keeping electronic records, handling electronic signatures and performing audit trails.
• Expertise in preparing all required documents for Computer System Validation CSV lifecycle, including Validation Master Plan VMP , Installation Qualification IQ , Operational Qualification OQ , Performance Qualification PQ and Validation Summary Report VSR .
• Developed URS User Requirement Specification and FS Functional Specification documents with detailed requirement breakdown.
• Experience in designing Gap analysis, Remediation plans and Requirement Traceability Matrix RTM .
• Working experience in reviewing, modifying and writing Standard Operating Procedures SOP
• Conducted Front-end testing, GUI and Functionality testing and regression testing on AERS using QTP.
• Thorough understanding of FDA Regulations, especially 21 CFR Part 11, 50, 58, 210, 312, 314, 820.
• Proficient in writing SQL queries for backend testing and maintaining databases.
• Experience in designing test plans, test cases and test scripts in Quality Center and also manual testing.
• Good Knowledge on JD Edwards enterprise one Application.
• Sound understanding in planning manual and automated testing, including load, stress and performance testing, positive, negative, system, integration, data driven, smoke, sanity, functionality and many other testing.
• Expertise in Annex 11 and FDA regulations.
• Proficient in Technical Writing with strong experience in developing Enterprise Lifecycle documentation required for application development projects like Project Plan, URS, FRS, RTM, Test Plan, Test Cases and Support Plan.
• Exceptional knowledge in laboratory analytical instruments including Gas chromatography, UV spectrophotometer, PH Meter, Incubator, Autoclave.
• Very good interpersonal skills, very comfortable with teamwork/independently and also able to work as a productive team member.
• Extensive knowledge on FDA regulations through which I could work on an accelerated or fast paced work environment with minimum supervision or less supervision, and with in-depth knowledge on cGXP.

Technical Skills

Professional Experience

Confidential

Lead Validation Analyst

Responsibilities:

• Reviewed and understood the user requirements and functional requirements.
• Followed the Waterfall methodology of SDLC life cycle during the project.
• Worked with different modules of Thermo LIMS like Sample Management, Conduct Test, Incidents, Certificate of Analysis report, Labeling, Templating.
• Validated the new functionality and roles for the integration of instrument with LIMS.
• Involved and contributed in the drafting of Data Integrity Risk Assessment DIA and developed the scope for testing with respect to DIA.
• Worked with the SME's to understand the scope, current and future state of the implementation.
• Documented the test cases using HP Quality Center.
• Gathered business requirements and participated in the designing of the Validation Master Plan VMP and Testing Criteria.
• Performed Configuration testing, Functional testing and Regression Testing.
• Documented defects identified the severity and priority of the defects and communicated with developers in fixing, providing supporting information for the defects and closing them.
• Scheduled and participated in scrum meetings with small team involving developers and Administrators to discuss the status of bugs, fixes and any outstanding issues.
• Reviewed, revised and implemented Standard Operating Procedures as per the new user requirement specification and functional requirement specifications.
• Worked on the requirement traceability of the requirements with the test cases and linked the defects to the corresponding tests in Quality Center.
• Used MS SharePoint as a repository for sharing and storing the documents related to the project.
• Executed the test cases and documented the Test Closure report detailing the tests and the defects.
• Worked on the test scripts execution of OQ, PQ of LIMS for the equipment interfacing project.
• Used SQL queries to filter data from the database for the validation test scripts.
• Involved in documenting Validation deviation report and worked with developers in determining its root cause, impact assessments and the corrective action.
• Led the testing team by assigning the test scripts to individuals and providing daily status updates to the project manager.
• Generated reports describing the status and the progress of the project.
• Performed the validation of LIMS for 21CFR part11 compliance by reviewing IQ, OQ, and End to End testing scripts.

Confidential

Technical Writer/QA

Responsibilities:

• Develop data flow diagrams and step by step procedures.
• Develop User manuals for SCI NET Supply Chain Information Network application.
• Distill complex concepts into easily understandable narrative.
• Organize material and complete writing assignment according to FDA Standards.
• Work with specialized cross-functional teams to develop and/or revise policies, processes, and procedures for Management Controls, Design Controls and Risk Management.
• Review published materials and recommend revisions or changes in scope, format, content, and methods of reproduction and binding.
• Develop and review complex flow charts and process flow diagrams
• Design, develop and review high level corporate documents such as process, procedure, forms, templates and spreadsheets.
• Develop and review Technical manuals.
• Develop procedure documents for Internal Audit, Supplier Quality, Document Change control, Training etc.
• Develop template documents for Risk Management like Design Failure Mode and Effective Analysis DFMEA , Fault Tree Analysis FTA , Periodic Risk Review and Performance Failure Mode and Effective Analysis PFMEA .
• Prepare RACI Responsibility, Accountability, Consultation and Inform diagrams for all the process and procedure documents as required.
• Develop SIPOC tables Supplier, Input, Process, Output and Consumer , Metrics and FMEA Failure Mode and Effectively Analysis for the process and procedures.
• Research the requirements, interview SME Subject Matter Experts, draft documents, and send documents through the review cycles, update documents, process documents through the release process.
• Develop procedure document for Global Corrective and Preventive Action CAPA for Quality Trackwise System.
• Develop manuals for FGRP Finished Goods Requirements Planning system and Cognos from a user's perspective.
• Prepare User Requirement Specifications and Technical Requirements Specifications for FGRP system.
• Request Change Requests for changes in documents, requirements, FMEAs and Flows and solve them.
• Work on Training Requirements, Courses and Modules.

Confidential

Validation Analyst

Responsibilities:

• Worked on various lab equipments such as HPLC, GC, UV-Spectrometer, FTIR and other several analytical lab equipments.
• Validated HPLC, GC and Autoclaves and written suitable Validation protocols.
• Reviewed validation deliverables such as Validation Master Plan VMP , validation protocols IQ's, OQ's and PQ's and validation summary report.
• Validated several Medical device Electronic systems as per FDA regulations and provided suitable result in accordance with the current regulations.
• Responsible for the development of inter-departmental project management for Operations-Validation-QA activities and the execution of project and equipment qualifications, validations, re-qualification and re-validation of manufacturing systems, equipment and processes in an aseptic manufacturing facility.
• Reviewed and documented batch records with greater attention on major and minor details with minimum supervision.
• Performed equipment validation, cleaning, facility qualifications for all the phases to check in accordance with FDA regulation.
• Conducted GAP analysis to check whether the functionality matches the proposed requirements.
• Validated HPLC, MS, FT-IR and provided suitable results and also written validation protocols, IQ, OQ, and PQ.
• Introduced test scripts, testing methodologies and user manuals for Adverse Event Reporting System to ensure compliance in accordance with 21 CFR Part 11, 210, 211.
• Reviewed, developed, drafted and enhanced SOP's.

Confidential

Validation Engineer/Analyst

Responsibilities:

• Developed and executed validation guidelines for testing cGMP and cGCP Current Good Manufacturing and Current Good Clinical Practice sensitive transactions
• Maintained all laboratory and manufacturing processes were in compliance with FDA Regulations, particularly 21 CFR Part 11, 21 CFR 820.
• Created and maintained SOPs/Guidelines documents on implementation of process changes and novel equipment.
• Coordinated with users to map out user requirements
• Validated gas chromatography, spectrophotometer, autoclaves, and incubators.
• Managed projects related to installations and modifications to existing facilities and processes under tight timelines
• Reviewed CAPA problem definitions, root causes, investigations, corrective action plans, and effectiveness checks for accuracy and integrity, assisting in resolution of investigation for FDA commitments.
• Managed quality processes in accordance with Food and Drug Administration FDA guideline 21 CFR 820 QSR requirements and standards ISO 13485 .
• Assisted in establishing validation project plans, set acceptance criteria, and defined the data requirements necessary to ensure that validation work is compliant with FDA regulations.
• Performed Review and Gap Analysis on legacy systems in compliance with 21CFR Part 11.
• Developed Installation IQ , Operational OQ and Performance Qualification PQ protocols. Prepared validation summary reports including deviation investigation and resolution and standard operating procedures.
• Reviewed and analyzed validation test results.
• Performed Revalidation assessment for validated laboratory equipment's and software systems.
• Participated actively in project meetings and discussion.

Confidential

Validation Engineer/Analyst

Responsibilities:

• Wrote test method validation protocols for equipment used for packaging inspections.
• Authored equipment validation documents using the GAMP compliance principals.
• Authored and supervised execution for IQ and OQ protocols for washing equipment.
• Developed validation documents for Process Validation Remediation to support engineering documents and process equipment.
• Defined and wrote Standard Operating Procedures SOPs in accordance with FDA regulations for the manufacturing of medical devices.
• Designed and developed initial startup process and procedure for the manufacturing line of cutting and lab devices.
• Prepared Validation Reports for Laboratory Equipment
• Review and Approve Equipment Validation Protocols

Confidential

Clinical Data Analyst

Responsibilities:

• Entry of clinical data into Clinical Trial Management Systems and administration of documents to produce efficient, quality data management products that meet customer needs.
• Developed Validation Master Plan and test plan. Involved in the preparation of Validation Summary Report.
• Prepared Technical Documentation such as technical manuals and requirement documents, etc.
• Designed Installation guides and Release Notes for the working application.
• Performed and implemented peer reviews of product documentation.
• Performed UAT, GUI and Functionality Testing of the applications.
• Validated the clinical data by checking for missing, incorrect or duplicate values.
• Validated the lab data and resolved issues related to units and conversions and missing lab ranges.
• Developed process procedures in compliance with FDA regulations using standard documentation like Standard Operating Procedures SOP's .
• Documented various modules of the test plan in compliance with 21 CFR Part 11.
• Reviewed templates for validation procedures of IQ, OQ and PQ's.
• Participated in preparing user requirement specifications and functional requirement specifications.
• Coordinated the review, query, and edit of all electronically-sourced clinical data as well as laboratory data collected on Case Report Form CRF .