GxP Validation Analyst

Highland Heights, OH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Hello;

GxP Validation Analyst

Job Location:-Highland Heights KY (Day 1 Onsite Candidate needs to work 5 Days at the Client Office)

Long Term

Project Overview

Global Instrument Software Validation Project covering 200 unique instruments. Scope includes:

Documenting and validating software installed on lab instrumentation per EMA guidelines

Migrating and adherence of instrument software management to PPD IT SOPs

Capturing requirements configurations and compliance documentation

Key Responsibilities

Gather and document requirements (URS software configuration)

Write and execute validation test cases (IQ OQ PQ as applicable)

Support to prepare requirements specifications infrastructure & data flow diagrams

Perform risk assessments and ensure traceability of requirements risks tests results

Support SOP migration and alignment with PPD IT practices

Communicate effectively with lab IT QA and vendor teams

Required Skills

Strong technical writing & documentation skills

Experience in software validation (lab instruments / GxP systems)

Knowledge of EMA guidelines Annex 11 GAMP 4

Ability to create infrastructure/data flow diagrams

Detail-oriented with strong communication and stakeholder engagement skills

6 9 years relevant validation experience (pharma / biotech / CRO )

Familiarity with CSA Principles

Hello; GxP Validation Analyst Job Location:-Highland Heights KY (Day 1 Onsite Candidate needs to work 5 Days at the Client Office) Long Term Project Overview Global Instrument Software Validation Project covering 200 unique instruments. Scope includes: Documenting and validating software insta...