Validation Lead

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

Job Description:

Requirements:

• 
  
• 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.
    
    Responsibilities:
    
    
    • 
      
    • 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