CSV Compliance – IT Quality Consultant

Do you have thorough knowledge of global regulatory requirements for CSV?

We are working with a pharmaceutical client in southern Connecticut who is seeking a senior IT Quality Consultant to support the compliance activities for the Computer System Validation (CSV) function. The ideal candidate will support and impact daily QA operations as well as overall quality improvement plans with geographically and culturally diverse teams. Thorough knowledge of global regulatory requirements for CSV, including 21 CFR Part 11 and predicate rules is required.

To qualify for this consulting role, you will be an analytical thinker who can identify problems and uncover root cause.

Additional capabilities include:

  • Extensive knowledge of QMS, including deviations, CAPAs, effectiveness checks and change controls
  • Direct QA oversight experience of QMS support for GxP IT/computerized systems
  • Experience creating, revising and implementing documentation to support computer systems operations
  • Experience using TrackWise for CAPA and change management
  • Knowledge of GAMP5, SDLC and IT infrastructure, including SaaS, data quality, data integrity and data management best practices
  • Experience in a GxP in biopharmaceutical/pharmaceutical industry.

Job ID: 1803-5534
Software Quality Associates is an equal opportunity employer and supports workforce diversity.