Sujha Bajracharya Email & Phone Number | • Over 2 years of experience in Validation with strong background in Computer System Validation Technical Writing including specialization in 21 CFR part 210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP). • Excellent experience in the validation of highly regulated enterprise level business systemsSiebel CRM, Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS),Adverse Event Reporting System (AERS), TrackWise, Inventory Management System and Remedy. • Professional experience in GXP (GMP, GLP, GCP), 21 CFR Part 11, GAMP5 for Pharmaceutical/Biotech manufacturing. • Good working experience with LabWare LIMS software involving tracking raw materials and samples, modelling work flows, managing data collection and reporting and communicating this information to corporate systems, end users. • Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA, MHRA rules and regulations. • Experience in utilities and facilities qualification, equipment qualification, and computer validation. • Experience with Factory Acceptance Test (FAT). • Good understanding of 21 CFR Part 11, 210, 211, 820, GAMP 5 and associated FDA, GCP/ICH guidelines. • Full validation life cycle experience including developing and maintaining SDLC for validated systems, Validation Plans, IQ/OQ/PQ/RTM, and validation reports. • Developed and reviewed Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM). • Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards. • Experience in using quality center to manage testing artifacts. • Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment. • Ability to work both independently and in a team-oriented working environment.

Sujha Bajracharya

• Over 2 years of experience in Validation with strong background in Computer System Validation Tec...
Harmans, Maryland, United States

*50 free lookup(s) per month.

No credit card required.

Sujha Bajracharya’s Email sbajracharya@biotech.com

Sujha Bajracharya’s Phone Numbers

Get SUJHA’s Phone Number (For Free)

Social Media

Sujha Bajracharya’s Location Harmans, Maryland, United States

Sujha Bajracharya’s Current Industry Psc Biotech

Sujha Bajracharya’s Prior Industry Icq Consultants | Neogenomics Laboratories

Not the Sujha Bajracharya you were looking for?

Find accurate emails & phone numbers for over 700M professionals.

Work Experience

Psc Biotech

Validation Engineer III

2022-05-01 00:00:00 - Present

Icq Consultants

Consultant II

2021-01-01 00:00:00 - 2022-05-01 00:00:00

Neogenomics Laboratories

CSV engineer

2019-08-01 00:00:00 - 2020-07-01 00:00:00

Skills

No Skills Available

Languages

No Languages Available

FAQ About Sujha Bajracharya

Sujha Bajracharya is located at
Harmans, Maryland, United States

Sujha Bajracharya is a • Over 2 years of experience in Validation with strong background in Computer System Validation Technical Writing including specialization in 21 CFR part 210,211,820 compliance and GAMP, GxP’s (GMP, GLP and GCP). • Excellent experience in the validation of highly regulated enterprise level business systemsSiebel CRM, Laboratory Information Management System (LIMS), Clinical Trial Management System (CTMS),Adverse Event Reporting System (AERS), TrackWise, Inventory Management System and Remedy. • Professional experience in GXP (GMP, GLP, GCP), 21 CFR Part 11, GAMP5 for Pharmaceutical/Biotech manufacturing. • Good working experience with LabWare LIMS software involving tracking raw materials and samples, modelling work flows, managing data collection and reporting and communicating this information to corporate systems, end users. • Experience in developing and reviewing User Requirement Specifications (URS), Functional Requirement Specifications (FRS) and Design Specifications (DS) in compliance and conformance with FDA, MHRA rules and regulations. • Experience in utilities and facilities qualification, equipment qualification, and computer validation. • Experience with Factory Acceptance Test (FAT). • Good understanding of 21 CFR Part 11, 210, 211, 820, GAMP 5 and associated FDA, GCP/ICH guidelines. • Full validation life cycle experience including developing and maintaining SDLC for validated systems, Validation Plans, IQ/OQ/PQ/RTM, and validation reports. • Developed and reviewed Test Plans, Validation protocols (Installation Qualification - IQ, Operational Qualification - OQ and Performance Qualification - PQ), Test Summary Report and Requirement Traceability Matrix (RTM). • Expertise in developing Test Strategies, Test Scripts, Test Cases, Test Plans, Test Procedures, Test requirements and testing standards. • Experience in using quality center to manage testing artifacts. • Experience in preparing Risk assessment, Regulatory Assessment, Technical Assessment, Remediation Plan and Deviation Reports for FDA regulated environment. • Ability to work both independently and in a team-oriented working environment.