Avash Shrestha
SUNNYVALE,CA
Summary
Results-driven professional with over 5 years of experience in Computer Systems Validation and Quality Assurance. Led the planning and implementation of multiple new Electronic Quality Management System (eQMS) systems, resulting in improved efficiency and compliance. Experienced in developing and documenting Validation Master Plans, Validation Summary Reports (VSR), Requirement Traceability Matrix (RTM), Standard Operating Procedures (SOPs), Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and Work Instructions. Extensive knowledge of FDA regulations, including 21 CFR Part 11 Electronic Records, Electronic Signatures, and Audit Trails. Strong understanding of Data Integrity principles, including the ALCOA+ principles. Proficient in reviewing and approving User Requirements Specifications (URS), Functional Requirements Specification (FRS), Design Specification (DS), Test Plan, and Test cases. Skilled in conducting Risk Analysis, Gap Analysis, and Corrective and Preventive Action (CAPA). Excellent communication and technical writing skills.
Overview
5
5
years of professional experience
Work History
IT SYSTEM VALIDATION ENGINEER
Alexza Pharmaceuticals
11.2022 - Current
- Participated in the planning and implementation of DOT Compliance EQMS system, ensuring alignment with project objectives and regulatory requirements.
- Collaborated with internal teams to identify their needs and requirements for DOT Compliance EQMS, facilitating effective communication and project alignment.
- Coordinated with cross-department team members to ensure adherence to DOT Compliance EQMS project requirements, deadlines, and schedules, ensuring successful project completion.
- Provided comprehensive training and support to 107 employees and internal teams on DOT Compliance EQMS functionality and best practices, improving user adoption and system utilization.
- Developed validation master plans, Performance Qualification (PQ), and Standard Operating Procedures (SOPs) for DOT Compliance EQMS to ensure regulatory compliance, demonstrating a strong understanding of validation processes.
- Analyzed pre-release software titles for DOT Compliance EQMS for compliance with User Requirement Specifications (URS) and reported any deficits to the appropriate personnel, including vendors, ensuring software quality and compliance.
- Authored Work Instructions for both the Information Technology (IT) and Quality Assurance (QA) departments for DOT Compliance EQMS, including comprehensive training curriculum, improving operational efficiency and user understanding.
- Planned and executed the migration of required documents and data from the old Product Lifecycle Management system to the new DOT Compliance EQMS, ensuring data integrity and system functionality.
- Led the project as project lead or acting project manager for DOT Compliance EQMS implementation, overseeing project milestones, timelines, and deliverables.
- Worked closely with external vendors for DOT Compliance EQMS to ensure a smooth transition and promptly address any issues that arose during the migration process, maintaining positive vendor relationships and project progress.
- Conducted data mapping and analysis for DOT Compliance EQMS to guarantee accurate transfer of all data from the old PLM system to the new EQMS, ensuring data integrity and system reliability.
- Created and executed test plans for DOT Compliance EQMS to validate the proper functioning of the new system, ensuring system quality and compliance.
- Developed user training materials and provided training sessions to employees on DOT Compliance EQMS, facilitating successful system adoption and utilization.
- Reviewed User Requirement Specifications (URS) for DOT Compliance EQMS to verify compliance with regulatory requirements and industry standards, ensuring system quality and compliance.
CSV/Validation Engineer
Terumo Medical Corporation
04.2020 - 11.2022
- Collaborated with internal groups to create project documents and performed verification and validation testing in an FDA-regulated environment.
- Participated in performing Part 11 assessments, with a focus on Electronic Records (ER), Electronic Signatures (ES), and Audit Trails following 21 CFR Part 11 regulations.
- Gathered requirements, reviewed specifications documents, and authored/reviewed related documents such as Validation Plan, Test Plan, Requirements Specification, Functional Specifications, Qualification Protocol, and Test Cases.
- Developed Risk Assessments and 21 CFR Part 11 Assessments.
- Maintained the Requirements Traceability Matrix (RTM) to track requirements during the QA Testing Phase.
- Developed test plans, test strategies, and test scripts for validation testing, along with the Test Summary Report (TSR).
- Authored user requirements, IOQ protocols, and validation final reports for various automation software
- Ensured documentation of all aspects of the Computer System Validation Life Cycle per 21 CFR Part 11, GLP, and GDP.
- Participated in writing SOPs for the Change Control process
- Mentored junior engineers in best practices for validation engineering methodologies improving team skillsets.
Validation Analyst
Biologics Consulting
01.2018 - 04.2020
- Contributed to the creation of project documents, including Validation Plan and User/Functional Requirements Specification (URS/FRS), in accordance with Standard Operating Procedures (SOPs).
- Authored Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) Protocols to ensure system compliance.
- Collaborated in the development of Requirements Traceability Matrix (RTM) and Validation Summary Report (VSR) to provide traceability and summarize validation activities.
- Assisted the Validation team in periodic review to ensure system compliance over time.
- Interacted with clients to gather requirements and update test cases according to their needs.
- Responsible for ensuring that all business requirements were covered in the test scripts to ensure system functionality.
Education
MBA - Management Information Systems
California Intercontinental University
Irvine, CA06.2019
User Experience And User Interface Certification - User Experience And User Interface
Springboard
San Francisco, CA07.2020
MBA - Marketing Research
University of Bridgeport
Bridgeport, CTSkills
- GAMP 5
- Root Cause Analysis
- FDA CFR Part 11
- GxP (Good Manufacturing Practice)
- CSV (Computer System Validation)
- Validation Lifecycle (IQ/OQ/PQ)
- URS (User Requirement Specification)
- FRS (Functional Requirement Specification)
- Validation Documentation (Plans, RTM, DS)
- Test Script Development
- Change Control Management
- SOP Authoring
- Data Integrity (ALCOA)
- Risk Management
- Quality Management (QMS)
- Compliance (Regulatory)
- Non-conformance Management
- CAPA (Corrective and Preventive Action)
- Root Cause Analysis (RCA)
- Project Management
- Requirements Gathering & Analysis
- Traceability Matrix Management
- Project Coordination
- Communication Skills
- Software Development Life Cycle (SDLC)
- Version Control Systems (VCS)
- Technical Writing
Timeline
IT SYSTEM VALIDATION ENGINEER
Alexza Pharmaceuticals
11.2022 - Current
CSV/Validation Engineer
Terumo Medical Corporation
04.2020 - 11.2022
Validation Analyst
Biologics Consulting
01.2018 - 04.2020
MBA - Management Information Systems
California Intercontinental University
User Experience And User Interface Certification - User Experience And User Interface
Springboard
MBA - Marketing Research
University of Bridgeport
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