Narayan B Khadka
Csv Engineer @NeoGenomics Laboratories
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WORK HISTORY
Csv Engineer @NeoGenomics Laboratories
Aliso Viejo, CA, US
Work ExperienceCSV Engineer 08/2019-Till DateNeoGenomics Laboratories Aliso Viejo, CAThe scope of this project is do end to end validation of label printer and change control management of the system using track wise.Responsibilities:• Prepared validation deliverables to assure compliance with 21 CFR Part 11 (Electronic Signatures and Records) and FDA Regulations for Software validation.• Completed validation of a product label printer.• Involved in the change management process by assessing the impact of changes on the validation status of computer systems on Trackwise.• Reviewed change-control documents, perform impact assessment, and submitted for approval.• Participated in gathering, documenting, and finalizing User Requirements Specifications (URS), Functional Requirements Specifications (FRS).• Created and executed Test cases and generated Report in compliance with 21 CFR part 11 requirements.• Authored documentation for all aspects of the computer systems validation in accordance with FDA regulations, 21 CFR part 11, including Validation Plan, Risk Assessment and Protocols for Installation Qualification (IQ), Operation Qualification (OQ), and Performance Qualification (PQ). • Created Requirements Traceability Matrix (RTM).• Involved in creating Working Instructions (WIs) for different users of the applications.• Drafted Validation Summary report (VSR) and assisted the team to complete the project successfully.
EDUCATION
Tribhuvan University
BBS, Sales and Marketing Operations/Marketing and Distribution/Accounting/Finance
Nepal jobs
MBS , International Marketing, Consumer Electronics
Shree Sarba Mangala HSS
school level , Education
Tribhuvan University, Institute of Medicine, Maharajgunj Medical Campus, Kathmandu
MBS, Specialized Sales, Merchandising and Marketing Operations
International American University, Los Angeles
Master of Business Administration (MBA), Marketing/Marketing Management, General
ABOUT NARAYAN B KHADKA
Mobile:(66••••••75Email: v••••••••@gmail.comProfessional Summary• Over 4 years of experience as a Computerized Systems Validation Engineer with extensive knowledge of computer system validation in compliance with FDA standards.• Good knowledge in pharmaceutical/medical device regulations, FDA 21 CFR Part 11, Part 210, Part 211, Part 820.• Worked closely with validation teams in developing and reviewing the User Requirement Specifications (URS), Functional Requirement Specifications (FRS) Design Specification (DS).• Experience in validation practices with a good understanding and practice of GDP (GMP, GLP,) and GAMP 5 methodology.• Comprehensive knowledge on validation strategy and guidelines.• Experienced in authoring validation deliverables and in development of validation protocols such as Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ) for the related applications and exposure on Standard Operating Procedures (SOPs) and User Acceptance Testing (UAT).• Authored Risk Assessment report, Test Protocols reports, Requirement Traceability Matrix (RTM) and Validation Summary Report (VSR).• Excellent team player, good communication skills, ability to learn in a fast-paced environment.Skills Computer System Validation GxP: GMP, GLP SDLC Installation Qualification (IQ) Protocol Operational Qualification (OQ) Protocol Performance Qualification (PQ) Protocol 21 CFR Part 11 GAMP5 Risk Assessment Microsoft Office MS Visio User Acceptance Testing Data integrity Requirement Traceability Matrix Discrepancies/Deviation CFR Part 820
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