Sierra Business Solution LLC
Sierra Business Solution LLC

GxP Computer System Validation Specialist Wilmington - DE - Delaware

Wilmington, DE, US • Posted 3 hours ago • Updated 3 hours ago
Contract Corp To Corp
Contract W2
12 Months
On-site
$65/hr
Fitment

Dice Job Match Score™

🔢 Crunching numbers...

Job Details

Skills

  • Computer System Validation
  • GxP Compliance
  • 21 CFR Part 11
  • GAMP 5
  • Risk-Based Testing

Summary

****PLEASE NOTE The rates may be negotiable based on experience, education, geographic location, and other factors..****

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 11820, GxP, GAMP 5, SOX, EU Annex 1122, ISO 9001, ITIL, EU Anness 22, ISO 9001, ITIL, Auditinspection readiness, periodic reviews, access roster and audit trail reviews, DeviationCAPA management, SOPpolicy compliance processes

Authoring of URSFS, protocols, final reports, validation planreport

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

` )

Employers have access to artificial intelligence language tools (“AI”) that help generate and enhance job descriptions and AI may have been used to create this description. The position description has been reviewed for accuracy and Dice believes it to correctly reflect the job opportunity.
  • Dice Id: 90911958
  • Position Id: 41782
  • Posted 3 hours ago
Create job alert
Never miss an opportunity! Create an alert based on the job you applied for.
More jobs at Sierra Business Solution LLC in Wilmington, DE