Job Description

9758 Quality Engineer, Davie, FL, 6 Months contract
Sigma. Inc is looking for a Quality Engineer to work onsite with our team located in Davie, FL

Shift: Monday – Friday 8.00 AM – 05:00 PM
Duration: 6 months with possibility to extend
Temp to Perm: Depending on opens and performance

Responsibilities:

  • Review and approve CSV lifecycle documents (VMP, URS, FRS, HDS, Risk Assessments, IQ/OQ/PQ, RTM, Summary Reports).
  • Ensure risk-based validation approaches aligned with GAMP 5, 21 CFR Part 11, and Data Integrity (ALCOA+) principles.
  • Evaluate system changes through change control, assessing GxP impact and validation requirements
  • Support periodic reviews and re-validation activities for existing systems.

Digital Systems & Platforms

  • Act as Quality reviewer/approver for systems including:<...

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