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Radhika

Validation Engineer

PROFESSIONAL SUMMARY

Over 9 years of experience in Medical sciences, professional with broad based GxP experience in Process Validation Quality engineering, Validation Engineer, pharmaceutical, Medical Device equipment qualification, sterilization, supporting both proprietary and generic pharmaceutical industries.

Experience as a Validation engineer in FDA regulated Pharmaceutical and Cosmetic environment with emphasis on Equipment validation, process validation, testing and technical writing.

Extensive Experience as a Quality Engineer in the Pharmaceutical and Medical Device Industry across all Verticals with International Exposure.

High degree of proficiency in developing and reviewing Validation Master Plans, Validation Summary Reports, Standard Operating Procedures and Standard Working Practices

Working experience with 21 CFR part 11 guidelines including the electronic records, electronic signatures, audit trails, open and closed systems.

Professional experience in validation methodologies with good understanding of FDA, SOX, MHRA and ICH guidelines.

Experience in working with different types of validation environments, including the retrospective, concurrent validation, re-validation, process validation, equipment qualification and cleaning validation.

Experience in swabbing, sampling, TOC analyzer, Clean/Aseptic guidelines.

Extensive knowledge in Clean Hold studies, Coupon Studies, Dissolution and Gravimetric Analysis.

Expertise in developing Installation Qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ).

Experiencing in Corrective and Preventive Actions (CAPA) and suggesting the remediation plans to mitigate the non-compliance.

Proficiency in creating, reviewing and auditing Validation Master Plans (VMPs), Standard Operating Procedures (SOPs), Protocols and Validation Summary Reports (VSRs).

FDA regulated environment with good understanding of 21 CFR part 11, part 50, part 56, part58, part 210, part 211, part 820, ISO 13485, 14971, cGxP (GMP, GCP and GLP), Risk Assessment.

Experience in project management in conducting meeting with different groups to gather and develop the User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS).

Experience in drafting the Requirement Traceability Matrix (RTM) document to track the URS and FRS specifications.

Developed comprehensive Test Plans, Test scripts, Test Cases and Test Reports.

Experience with Laboratory Information Management System (LIMS).

Performed GAP analysis in identifying compliance gaps, developing corrective action and preventive action plans, and implementing those corrective action plans.

Excellent as a team player as well as independent worker as evidenced in the previous projects

Good ability to adapt to a fast paced environment and a quick learner. Highly organized and good time management skills.

WORK EXPERIENCE

Alcon, Houston, TX April 2017 - Till date

Validation Engineer

Responsibilities:

Involved in preparing documentation for all aspects of the computer system validation life cycle, in accordance with FDA design control and regulations, particularly 21 CFR Part 11

Gathered business requirements in compliance with 21 CFR part 11

Followed all the policies and procedures involved in the manufacturing operations in the development of catheters

Assisted the project manager in documenting SOPs, validation protocols (IQ, OQ, PQ) in the development of Catheters in production phase.

Reviewed and Authored User Requirements Specification, System Requirements Specification, System Design Specification documents, Traceability Matrices, Test Summary Reports and performed Risk Assessment.

Assessed regulatory impacting requirements have been categorized appropriately.

Review & understand the source configuration files and compare with values entered into system.

Prepared Test Plan and Test Summary Report for system, integration and regression testing.

Reviewed automated test scripts in HPQC 10.0

Actively involved in creating the Remediation Guidance document

Developed configuration verification plans and test scripts to verify the actual configuration values in comparison with the source configuration files.

Executed configuration validation plan in a controlled and qualified test environment.

Capture configuration test results and developed analysis reports. Documented the defects found and presented defects to the Integrated project team and arrive at appropriate disposition.

Prepare CAPA plan, write test cases, test scripts, test summary reports for overall product, part wise assessment and improvement and report concerns if any to the suppliers

Provided engineering support to the operational issues based on the existing procedures

Implemented the new raw materials for optimizing the costs incurred and process efficiency with the team lead

Conducted UAT (User Acceptance Testing) to make sure that all the user requirements are catered by the application

Extensively used Enterprise Data Management platform Documentum for maintaining validation life cycle documents

Performed production data analysis and suggested process parameters for process optimization, process control and product development

Assist QA team to plan, perform UAT & update team, project manager about bug status, defects & project validation status

Documented the Validation Summary Report (VSR)

Elanco, IN Sep 2015 to March 2017

Validation Lead

Responsibilities:

Extensively worked and thorough knowledge on J&J 8.1 SDLC methodology.

Involved in the product life-cycle from planning/designing to production release, following the waterfall development methodology.

Developed Migration Protocol which details the migration approach and methodology including the life cycle deliverables as per 21 CFR Part 11 Compliance.

Authored URS (User Requirements Specification)/ FRS (Functional Requirements Specification) document and reviewed DS (Design Specification) documents.

Was responsible for conducting functional Risk Assessment and authored Business Impact Assessment document.

Developed Test Protocol and reviewed UAT and System test scripts developed by testing team.

Acted as HP ALM admin and was responsible for uploading requirements into HP ALM.

Performed Dry Runs to make sure system functionality is working as expected.

Performed Executions in QA/Test environment and wrote Test Defect Reports.

Followed good test practices to document the test evidence (Screen Prints), Deviations,

Resolutions, and Corrective Actions.

Analyzed Test Scripts impact on GxP environment to check if it has covered functionalities in all cases like development, testing and production phases, which need to be in compliance with 21CFR Part 11 rules set by FDA.

Extensive interaction with 3rd party vendor, IT, Users, SME, Business Owners, and QA

departments to develop and maintain validation procedures and get the validation documents reviewed and approved.

Ensured requirements are met by completing a Requirement Traceability Matrix.

Managed traceability between requirements, design elements, and test cases in HP ALM.

Developed Test Summary Report and Migration Summary Report to summarize all validation activities.

Noven, Miami, FL March 2014 to June 2015

Validation Engineer

As a Validation Engineer, I was involved in validating and preparing documentation for SAP systems in compliance with FDA regulations and help implement Change Control Systems. Worked with oversight of deliverables authoring, review and approval, development and management of test plans, execution of tests, summary reports and final implementation of applications.

Responsibilities:

Created Process Maps, TMV-protocols and reports for remediation.

Responsible for the development and execution of Master Validation Plans, Risk Assessments, Operational Qualifications, Performance Qualifications and Validation Summary Reports.

Developed and executed IQ, OQ and PQ protocols for product, processes and equipment within the facility.

Performed GAP Analysis and prepared Remediation Plans to address the gaps identified.

Involved in validation process coordination within cross functional departments such as Technical Operations, Engineering, Quality Assurance, and Regulatory affairs.

Responsible for Creation, evaluation, and validation of product and process test methods and test method validations.

Developed and implemented processes consistent with the Continuous Improvement System through Lean Manufacturing.

Evaluated test protocols and reports to ensure that the testing is sufficient to meet regulatory requirements and quality objectives.

Developed functional Test Methods for design verification, process characterization, process validation, and finished product.

Planning, strategizing, and executing validation activities.

Incorporated FDA guidance and external standards into functional test methods and their validations.

Responsible for maintaining Quality System Regulations including Document Control and Record Control.

Developed documentation for all aspects of validation including risk assessments, and quality and regulatory assessments.

Set up design and development process as per 21 CFR 820.30 & ISO13485 requirements.

Responsible for verification of Design History file deliverables and reviewing the deliverables. Updated the DHRs, created ECOs and updated the Part drawings by Tech Review summary minutes.

Validation and Verification Activities for Medical devices - Performed assessments on previously validated process validation documents.

Established and maintained procedures for identifying valid statistical techniques required for establishing, controlling, and verifying the acceptability of process capability.

Co-ordinated with R&D, Product Development and Operations engineering teams to change product drawings, tolerances and modify inspection-sheets and set up sheets to provide validation deliverables.

Dr Reddy’s, India Sep 2011 to Dec 2013 Validation Analyst

Responsibilities:

Participated in Validation Life Cycle (VLC) planning, implementation and documentation. Wrote documentation for all aspect of the computer systems validation lifecycle, in accordance with FDA regulations, particularly 21CFR Part 11.

Maintained all the logs and documents through a document management system Documentation.

Followed the Standard Operating Procedure SOP's for Document management system.

Utilized Documentum for storage and retrieval of documents.

Responsible for storing and maintaining the documents to comply with 21 CFR Part 11 requirements.

Involved in documenting Validation Plan, Validation Protocol, Installation Qualification (IQ), Operation Qualification (OQ) and Performance Qualification (PQ) Specifications.

Documented URS (User Requirement Specification), FRS (Functional Requirement Specification) based on BPRS (Business Process Requirements).

Involved in writing the Risk Assessment documents, Test Summary Documents and Validation Summary Report (VSR) to summarize overall validation activities and to establish documented evidence that the system was validated according to the standards of 21 CFR Part 11.

Asserted validation documentation for complying with CGMP sensitive transactions.

Maintained the Requirement Traceability Matrix (RTM) to gauge the progress on a regular basis.

Developed test plans, test strategies, test scripts for validation testing along with the Test Summary Report.

Performed integration and regression testing to ensure software is not adversely affected and validate existing functionality.

Executed SQL queries for back-end analysis and testing of data.

Tracked product defects found during validation testing and report issue status and quality metrics.

Verified and resolved defects in each release and performed manual testing.

Involved in reviewing Corrective Action and Preventive Action (CAPA) and drafting Remediation plans for the project management approval after GAP analysis.

Executed test cases based on the test plan and in accordance with Good Documentation Practices (GDP).

Developed and documented Test Plan and Test Cases using specifications from the business Requirements.

Developed a road map by analyzing the Business Requirements for manual testing that included test objectives, test plans and test cases development.

Responsible for writing Validation Summary Report.

Performed critical reviews of batch records, testing results and engineering documents reported to Quality Assurance manager.

Reviewed and investigate deviations, excursions and CAPAs.

Provided excellent product free defects to end customers based on our Quality Assurance environment.

Environment: EDMS and SAS.

Gland Pharma, India June 2009 to Aug 2011

Validation Engineer

Responsibilities:

Develop and write analytical procedures, Cleaning validation protocols and reports upon completion of project.

Determine and/or recommended plans analytical methodology development program and objectives through joint consideration and collaboration with the R&D group.

Provides technical leadership and support to QC Laboratory in the integration of new methodology, techniques and/or instrumentation.

Review and approve Cleaning validation protocols, GMP documentation

Develops and executes Periodic review of computerized systems and applications

Develops and executes validation lifecycle documentation such as Change Control, URS, VMP, VP, FAT, Commissioning and IOQ protocols

Organized meetings with clients to meet their satisfaction

Prepared Annual Product Review reports

Statistical evaluation for Annual Product Review

Product recommendations after product evaluation

Perform laboratory investigations and peer review

Responsible for maintenance, testing, troubleshooting, calibration and repair on a variety of circuits, components, instrumentation for laboratory and process equipment related to the Pharmaceutical/Biotech industry.

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