Company: Katalyst Healthcares & Life Sciences
Posted on: March 19, 2023
- 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
- Good understanding of GxP standards.
- Well acquainted with all the phases of Validation Life Cycle
- 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
- Labeling Machine
Keywords: Katalyst Healthcares & Life Sciences, Bloomington , Validation Lead, Other , Bloomington, Indiana
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