Overview
On Site
Depends on Experience
Accepts corp to corp applications
Contract - W2
Contract - 12 Month(s)
No Travel Required
Skills
GxP Validation Analyst
validation test cases
infrastructure
EMA guidelines
Annex 11
GAMP 4
CSA Principles
Job Details
Title: GxP Validation Analyst
Location:- Highland Heights, KY - Day 1 Onsite
Duration: 6+Months
Location:- Highland Heights, KY - Day 1 Onsite
Duration: 6+Months
Exp: 9
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
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