Qualification and Validation Analyst

2 weeks ago


Indianapolis, IN, United States TCS USAAvance Consulting Full time

Must Have Technical/Functional Skills

Experience in executing equipment validation including IQ/PQ/OQ in regulated environment

Experience supporting in a GMP environment

Excellent written and verbal communication skills

Roles & Responsibilities

Author equipment qualification and validation packages

Plan coordination with equipment manufacturer or supplier for preventative maintenance

Technical review and execution of qualification/validation protocols

Execution of CSV initiatives

Apply knowledge of quality principles, GMPs, federal regulations and standard procedures to deliverables

Initiate CSV change controls on equipment



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