Computer Systems Quality Assurance (CSQA) with Validation (CSV)

  • Indianapolis, IN
  • Posted 6 hours ago | Updated 6 hours ago

Overview

On Site
$DOE
Full Time
Accepts corp to corp applications
Contract - Independent
Contract - W2
Contract - 8 day((s))

Skills

Quality Assurance
Veeva
ServiceNow
JIRA
HP ALM
Pharmaceutics
Medical Devices
System Testing
Enterprise Resource Planning
Manufacturing
Regulatory Compliance
Corrective And Preventive Action
Auditing
Inspection
Training
Computerized System Validation
QA Management
Risk Management
FOCUS

Job Details

Job Title: Computer Systems Quality Assurance (CSQA) with Validation (CSV)

Location: Indianapolis, IN (Onsite)

Duration: 12+ Months

Job Description:

Please not that 1 F2F round is mandatory.

Mandatory skills:

  • IT CSV Validation of IT systems
  • IT QA / QA eCompliance Manager
  • Experience with Veeva Quality Docs, ServiceNow, JIRA and HP ALM
  • Pharma industry experience is mandatory
  • Medical device experience is good to have

This Computer Systems Quality Assurance role will be responsible for supporting the expansion of client's ERP systems and associated applications to new and existing manufacturing sites. The role will deliver quality oversight to ensure assigned systems are developed and maintained, in compliance with corporate Computer System Validation (CSV) standards.

Total Yrs. of Experience: 7 to 12 years

Key Objectives/Deliverables:

Maintain Inspectional Readiness

  • Ensure supported systems are validated
  • Ensure all quality actions and commitments for supported areas are appropriately tracked in Quality/CAPA plans
  • Participate in self-inspections, audits, and supplier assessment activities to ensure the state of computer system validation is clearly and accurately understood
  • Ensure all Inspection Readiness materials are current and appropriate

Deliver Projects, Programs, and Support

  • Provide consulting and interpretation on client processes as related to the supported computer system
  • Provide training to customer areas on CSV-related topics as needed
  • Partner with Business, Business Quality, and IT customer areas to deliver business value
  • Understand customer, company, and Quality priorities
  • Review/approve documents per CSV expectations within agreed service levels, or clearly communicate when activities will be completed
  • Engage customers and QA management in appropriate discussions of risk management
  • Ensure suppliers of computer systems or services meet quality expectations
  • Escalate computer system quality issues to the appropriate persons
  • Strive for and promote consistency within the CSQA Organization

Streamline and Continuously Improve

  • Eliminate non-value-added activities in order to focus on activities which continuously improve assurance of quality
  • Identify opportunity for streamlining and simplification and assist in developing improved solutions
  • Understand external trends and potential ramifications for the supported IT area(s)
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