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Validation Lead

Company: Katalyst Healthcares & Life Sciences
Location: Bloomington
Posted on: March 19, 2023

Job Description:


  • Manufacturing Equipment Validation
  • Risk Assessment
  • 21 CFR Part 820
  • Change Control

    • Experience in validating Manufacturing Equipment.
    • Extensive validation experience in 21 CFR Part 11, Part 820.
    • Good understanding of GxP standards.
    • Well acquainted with all the phases of Validation Life Cycle (VLC).
    • Expertise in planning and execution of Validation Master Plan, requirements gathering (User Requirement Specifications).
    • Extensive experience in creating, reviewing and executing test protocols (Installation Qualification (IQ), Operational Qualification (OQ) and Performance Qualification (PQ)), Traceability Matrix and Validation Summary Report (VSR).
    • Expertise in technical writing and reviewing of Standard Operating Procedures (SOPs), Work Instructions.
    • Excellent knowledge and good working experience in executing Gap Analysis, and Change Control Process.
    • Extensive experience in performing Risk Assessment.


      • Chamber, Auto Claves, Freezers
      • Air Handler, Heater Chiller
      • Barcode Scanner
      • Mixing Tank
      • Weighing Balance
      • Laminor Flow Unit
      • Packaging Machine
      • Pressure Vessel
      • Purified Water System
      • Terminal Sterilizer
      • Lyophilizer
      • Labeling Machine
      • Dehumidifier

Keywords: Katalyst Healthcares & Life Sciences, Bloomington , Validation Lead, Other , Bloomington, Indiana

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