USA_Developer

Pay Rate range

$ 53.03 - 56.9=81/hr.

Job Description

Qualification

Bachelor of Science OR Bachelor of Technology OR Bachelor's in Pharmacy

Experience

Over 8+ years of overall experience with at least 5 years of experience in Computer System validation for GxP system

Knowledge, Experience and Skills

{

CORE CSV

21 CFR Part 11/820, GxP, GAMP 5, SOX, EU Annex 11/22, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Audit/inspection readiness, periodic reviews, access roster and audit trail reviews, Deviation/CAPA management, SOP/policy compliance processes

Authoring of URS/FS, protocols, final reports, validation plan/report

High-level understanding of Veeva Vault suits

Risk-based testing aligned to CSA fundamentals

}

AND

{

R&D

High-level understanding of Biostatistics, Clinical, Discovery, Medical Affairs, Pharmacovigilance, Regulatory Affairs, RPA GxP BOTs, R&D AI GxP

` )

Skills

Category

Name

Required

Importance

Experience

SkillCategoryTest1_MN

Life Sciences

Computer System Validation

Yes

1

>7 years