Validation Lead

Are you a Computer Systems Validation Consultant with experience working with Jira?

SQA Group is partnering with a Boston-based biotechnology software provider who are preparing for a periodic review of their instance of Jira. This effort will include examining prior CSV artifacts and deliverables and uncovering gaps that may or may not have been documented as change controls. In addition to modifying existing documentation, the Validation lead will be responsible for developing new validation plans, scripts, trace matrix, and summary report. The ideal candidate would have prior experience validating Jira or have a deep understanding of Jira and it’s workflows/capabilities.

Critical Success Factors:

  • Experience on more than one project or more than two years as a Validation Lead in an FDA regulated environment
  • Moderate knowledge of Jira, including how it would be used for CAPA/Change Control
  • Experience performing computer systems validation with a risk-based approach
  • Ability to create and execute computer systems validation plans
  • Ability to create and execute computer systems validation scripts
  • Experience creating trace matrices and validation summary reports
  • Experience providing GAMP, Part 11, or Annex 11 expertise to key stakeholders
  • Strong negotiation and communication skills

Job ID: 2009-5922
SQA Group is an equal opportunity employer and supports workforce diversity.

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