Validation Lead

Company : Katalyst Healthcares & Life Sciences

Country: United States

Location : Bloomington, Indiana

Post: Thu, 23 Mar 2023 06:34:31 GMT

Expires: Thu, 20 Apr 2023 23:59:59 GMT

Apply Job : Apply Online

—————————— 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