Start searching
Back to Jobs
Recently postedOther

Computer System Validation - GxP/R&D

ASCII Group LLCWilmington, DE🇺🇸United States

Quick overview

SeniorityMid Senior
Work modeOn Site
LocationWilmington, DE, United States
CompliancePharmacovigilanceRegulatory ComplianceVaultITIL

Job description

Hi ,
The following requirement is open with our client.
Title                                        : Computer System Validation - GxP/R&D
Location                               : Wilmington, DE (Onsite)
Duration                               : 6+ Months
Relevant Experience (in Yrs.): 8+
Looking for only W2/C2C

Job Description
We are seeking an experienced Senior Computer System Validation (CSV) Specialist with 8+ years of overall experience, including at least 5 years of hands-on experience validating GxP-regulated computer systems. The ideal candidate will have strong expertise in regulatory compliance, risk-based validation, validation lifecycle documentation, audit readiness, and quality processes, along with an understanding of pharmaceutical and life sciences R&D systems.
Key Responsibilities
  • Execute and support end-to-end CSV activities for GxP-regulated systems in compliance with applicable regulatory requirements.
  • Prepare, review, and maintain validation documentation, including URS, Functional Specifications (FS), validation plans, test protocols, execution evidence, and final validation reports.
  • Apply risk-based testing and Computer Software Assurance (CSA) principles to validation activities.
  • Support audit and inspection readiness, periodic reviews, access roster reviews, and audit trail reviews.
  • Manage deviations, CAPAs, validation issues, and compliance documentation in accordance with established SOPs and quality policies.
  • Support validation and compliance activities for R&D applications, including clinical, regulatory, pharmacovigilance, and medical affairs systems.
  • Contribute to compliance assessments for Veeva Vault applications, RPA-based GxP bots, and AI-enabled solutions in regulated R&D environments.
Required Skills
  • Strong knowledge of GxP regulations, 21 CFR Part 11/820, GAMP 5, EU Annex 11, SOX, ISO 9001, and ITIL.
  • Hands-on experience in Computer System Validation for GxP-regulated systems.
  • Expertise in validation lifecycle documentation, including URS, FS, validation plans, test protocols, and final reports.
  • Experience with risk assessments, risk-based testing, and CSA fundamentals.
  • Knowledge of audit readiness, periodic reviews, access management, audit trail reviews, deviations, and CAPA management.
  • Understanding of pharmaceutical and life sciences R&D processes, including Clinical, Biostatistics, Discovery, Medical Affairs, Pharmacovigilance, and Regulatory Affairs.
  • High-level understanding of Veeva Vault applications and emerging GxP technologies, including RPA bots and AI-enabled solutions.
MUST-HAVE SKILLS
  • GxP Computer System Validation (CSV)
  • 21 CFR Part 11 / GAMP 5
  • CSV Documentation
  • Risk-Based Testing / CSA

Similar jobs

Apply