Job Description :
Validation Consultant
Round Lake, IL 60073
Experience in validating the Computerized System.
Extensive validation experience in 21 CFR Part 11.
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.
Experience in validating few of this below equipment:
Particle Measurement System
FT-IR Spectrophotometer
Gas Chromatography
Liquid Chromatography
Carbon Dioxide Headspace Analyzer
Differential Scanning Calorimeter
UV-Vis Spectrophotometer
Malvern Mastersizer
Mass Spectrometer
TruScan RM Analyzer
MTS System
ICP-OES Spectrometer
Mitutoyo Co-ordinate Measurement System
TOC- Total Organic Carbon
Sensitech TempTale Manager
Ellab Data Logger

Client : IDC


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