-
ID
#49527392 -
Job type
Contract -
Salary
TBD -
Source
VTekis Consulting LLP -
Date
2023-03-23 -
Deadline
2023-05-22
Validation Lead (Super Urgent)
Indiana, Bloomington, 47401 Bloomington USAVacancy expired!
Description:Experience in validating the 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. Experience in validating few of this below equipment:Chamber, Auto Claves, FreezersAir Handler, Heater ChillerBarcode ScannerMixing TankWeighing BalanceLaminor Flow UnitPackaging MachinePressure VesselPurified Water SystemTerminal SterilizerLyophilizerLabeling MachineDehumidifierThanks and Regards,Mohammed Ilyas,PH - 229-264-4029 Text - 770-852-8474.
Vacancy expired!