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Validation Lead

Validation Lead

Katalyst HealthCares & Life SciencesOakdale, MN
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Roles & Responsibilities :

  • Experience in validating the Computerized System / Analytical Instrument. Extensive validation experience in CFR Part .
  • Good understanding of GxP standards. Good Knowledge in Data Integrity 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), QRA.
  • 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. Good communication skills and English fluency.
  • Experience in validating few of this below equipment : Particle Measurement System
  • FT-IR Spectrophotometer
  • Gas Chromatography
  • Liquid Chromatography
  • Carbon Dioxide Headspace Analyzer.

Note :

  • look for people with either Electrical, Instrumentation or Mechanical background with must have experience in Analytical Instrument Qualification.
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    Validation Lead • Oakdale, MN