Computer Systems Validation (CSV) Quality Assurance Specialist_REMOTE

Overview

Remote
Hybrid
Depends on Experience
Contract - W2
Contract - Independent

Skills

Computerized System Validation
Life Sciences
Quality Assurance
QA Management
Risk Management
Veeva
Auditing
Enterprise Resource Planning
System Testing

Job Details

Title: Computer Systems Validation (CSV) Quality Assurance Specialist

Location: Indianapolis, IN (Preferred)
Work Mode: Onsite / Remote

Shift: Eastern Standard Time (EST))

Experience Requirements

  • Total Experience: Up to 12 years
  • Relevant Experience: 7 12 years in IT Computer System Validation (CSV) and Quality Assurance


Mandatory Skills

  • Strong experience in IT CSV validation of IT systems
  • IT QA / QA eCompliance management experience

Validation experience with:

  • Clinical Trials Management Systems (CTMS)
  • Statistical Analysis Systems / Reports / Tools

Hands-on experience with:

  • Veeva Quality Docs
  • ServiceNow
  • JIRA
  • HP ALM
  • Pharmaceutical industry experience is mandatory

Desired Skills

  • Expertise in IT QA / eCompliance Management
  • Familiarity with regulated life sciences environments
  • Strong knowledge of CSV documentation standards and audit readiness

Industry Domain

Life Sciences / Pharmaceutical

Detailed Job Description

This Computer Systems Quality Assurance (CSQA) role supports the expansion of the client s ERP systems and associated applications across new and existing manufacturing sites. The role ensures systems are developed and maintained in compliance with corporate Computer System Validation (CSV) standards and regulatory requirements.

Key Responsibilities

Inspectional Readiness

  • Maintain inspection readiness for all supported systems.
  • Ensure systems remain validated and compliant with CSV standards.
  • Track quality actions and commitments through Quality/CAPA plans.
  • Participate in audits, self-inspections, and supplier assessments.
  • Keep all inspection readiness materials current and complete.


Project Delivery & Support

  • Provide consulting and interpretation on client processes related to supported computer systems.
  • Deliver training to customer areas on CSV and compliance topics.
  • Partner with Business, Business Quality, and IT to ensure business value delivery.
  • Review and approve documentation as per CSV expectations.
  • Facilitate risk management discussions with customers and QA management.
  • Ensure suppliers of computer systems/services meet quality expectations.
  • Escalate system quality issues to appropriate stakeholders.
  • Promote consistency and best practices within the CSQA organization.


Continuous Improvement

  • Eliminate non value-added activities and focus on quality improvement.
  • Identify and implement opportunities for process streamlining and simplification.

Stay informed on external regulatory and industry trends relevant to IT/CSV.

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