Shiva Dhakal

6 + years hands-on experience in Computer System Validation (CSV) which responsible for developing, drafting and implementation of Impact Assessment, Change Control, URS, FRS, DS, Validation Plan, Risk Assessment, GAP Analysis, Validation Summary Report and Requirement Traceability Matrix (RTM). Responsible for developing, drafting, and executing IQ, OQ, PQ protocols and participated in authoring and reviewing Project Plans, URS, FRS, and DS and ensure Security, Audit Trail and Electronic Signature requirements are documented. Experienced in 21 CFR part 11, 210,211,820 compliance and EU Annex 11, as well as GAMP 5 Risk based methodology for GxP Computer System (GLP, GCP, GMP) and GDP (Good Document Practice) guidelines.

Expertise in developing Data Integrity with ALCOA++ principles and Experienced with Electronic Document Management System (EDMS). Strong expertise in creating, populating, reviewing, and documenting SOPs and Test Plans, Test Cases, Test Procedures, Test Strategies, Test Reviews, Test Summary Reports, design and configuration specification, development, functional testing in compliance with FDA.

Experience in Temperature Mapping activity. Worked on the cross functional teams to resolve the Protocol Deviation or Discrepancy, Risk Assignment, Change Control using the root cause analysis tools such as 5 whys, fishbone diagram, FMEA, change control and CAPA.

Excellent

Organizational, Communications and Presentation Skills with an ability to interact and document proactively with all Internal and External Stake Holders. Ability to Train and Motivate all Level of Employees with exceptional Communication Skills. Always a Team Player and believe in the Team's Success rather than oneself. 4 years Management & Leadership experience in the field of Information Technology, Mathematics, Education & Journalism

Senior Facilities Validation Engineer - Advanced Bioscience Laboratory - Rockville, MD

(2023-04)

Implementing GxP, GDP, 21 CFR part 11/210/211/280 and data integrity for validation deliverables throughout the SDLC with following SOP's and GDP's for conducting validation deliverables

• Authored and reviewed Validation Project Plan, Computer System Risk Assessment, URS, FRS, DS, CS, IQ, OQ, PQ, Audit Report, RTM (Requirement Traceability Matrix), Periodic Review Report and VSR (Validation Summary Report).
• Testing experience demonstrated in developing, and documenting Test Plans, Test Cases (IQ, OQ and PQ), Deviations, Change Controls, and Test Summary Reports.
• Worked with QA, IT, and Subject Matter Experts (SME) to execute the qualifications protocol documents.
• Skilled in preparing validation documentation, review, and approvals skills in compliance with industry validation practices and Good Documentation Practices (GDP)
• Experience in performing Gap Analysis, solving deviation and discrepancy, and providing Remediation Plan to mitigate non-compliance.
• Participated in preparing Validation Deviations during validation tests and found the root cause of failure using tools such as cause and effect, 5 Whys and fishbone diagram.
• Performed CAPA investigation to find out the root cause.

Senior Validation Engineer - Adamson Analytical Laboratory - Corona, CA

(2022-05 - 2022-11)

Implementing GxP, GDP, 21 CFR part 11/210/211/280 and data integrity for validation deliverables throughout the SDLC with following SOP's and GDP's for conducting validation deliverables

• Authored and reviewed Validation Project Plan, URS, FRS, DS, CS, RTM (Requirement Traceability Matrix), IQ, OQ, PQ, Audit Report, Computer System Risk Assessment, Periodic Review Report and Validation Summary Report.
• Testing experience demonstrated in developing, and documenting Test Plans, Test Cases (IQ, OQ and PQ), Deviations, Change Controls, and Test Summary Reports.
• Worked with QA, IT and Subject Matter Experts (SME) to execute required document specifications.
• Thorough knowledge of Change Control Management Activities, Back-up and restore, disaster control, and Structured Change Control Procedures.
• Skilled in preparing validation documentation, review, and approvals skills in compliance with industry validation practices and Good Documentation Practices (GDP)
• Experience in performing Gap Analysis, reviewing, and performing Corrective and Preventive Action (CAPA).
• Participated in preparing Validation Deviations during validation tests and found the root cause of failure using tools such as cause and effect, 5 Whys and fishbone diagram.
• Performed CAPA investigation to find out the root cause.

Project Co-Ordinator - III - Medtronic Neurovascular - Irvine, CA

(2017-03 - 2022-05)

Followed SOP's and GDP's for conducting validation and Production deliverables.

• Participated in implementing 21 CFR Part 11, 210, 211 and 820 and data integrity for validation deliverables throughout the validation life cycle and product development.
• Collaborated with Subject Matter Expert (SME) and cross functional team to define and gather requirement specifications.
• Assist in Validation Plan and Reviewed the User Requirement Specification (URS), Functional Requirement Specifications (FRS) and Design Specification (DS).
• Participate in writing Validation Plan and Validation Summary Report.
• Write the test scripts for installation qualifications (IQ), Operational Qualifications (OQ) and Performance Qualifications (PQ).
• Maintained Requirement Traceability Matrix (RTM) to keep track of user requirements.
• Executed the test scripts and reported discrepancy.
• Participate in Risk Assessment, Work closely with QA and Val Lead for Requirement Risk Assessment (RRA).
• All discrepancy/deviations and test incidents were reported to team lead with procedures.
• Root cause analysis to investigate NCR, NCMR and CAPA process.
• Created and maintained Requirement Traceability Matrix (RTM) throughout the process.
• Monitored laboratory computer system compliance with global standard.

Manager - 7-Eleven Inc - Santa Ana, CA

(2016-04 - 2017-03)

As a manager in 7 Eleven, gained customer service knowledge, prepare daily/weekly work sheet, ordered daily/ weekly product, track inventory and safely handled cash money etc.

Mathematics Faculty Member - Multiple - Kathmandu, Nepal

(2010-01 - 2013-12)

In 4 years teaching profession with different college (National Open college and Asian School of management and information Technology, Kathmandu, Nepal) deliver excellent result in Mathematics subject. Teaching Method, material and passion create the record of the 100% pass in Mathematics.

Manager - Multiple - Kathmandu, Nepal

(2010-01 - 2013-12)

In 4 years managing performance in Brishaspati Books Publication Kathmandu and Shreenagar Educational Consultancy Kathmandu, Nepal was memorable because I was awarded by Best Performer title in two consecutive years. We exceed the company's goal in marketing as well as ratio of the profit.

Journalist - Multiple - Palpa, Nepal

(2002-01 - 2008-12)

In 7 years, Journalist journey, I stared as a news collector, news editor, news and documentary Presenter and leave the journalism as news chief. I worked in different media house like paper media, audio (F.M Radio) and television.

Master of Education - Mathematics - Texas Wesleyan University (2015)

Master of Education - Mathematics and Computer Science - Tribhuvan University (2010)

Bachelor of Education - Mathematics - Palpa Multiple Campus (2007)