Computer Systems Quality Assurance (CSQA)@ Indianapolis, IN)

Role: Computer Systems Quality Assurance (CSQA)
Location: Indianapolis, IN (Onsite)

Mandatory skills
IT CSV (Computer System Validation)
IT Quality Assurance (IT QA)  / QA eCompliance Manager
Experience with global patient safety, adverse event/product complaint reporting
Strong knowledge of GxP, FDA 21 CFR Part 11, Annex 11, and data integrity standards

Domain
Life Science

JD:
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.  

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)