QA Validation & Qualification Documentation Reviewer
Core
Review and approve qualification and validation documentation for pharmaceutical manufacturing processes, equipment, and computerized systems to ensure compliance with GMP regulations.
Role type
QA Validation & Qualification Documentation Reviewer
Builds
Validation packages, qualification reports, and lifecycle review records for sterile manufacturing and process validation.
Domain
Pharmaceutical manufacturing / Quality Assurance / GMP Compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP regulations knowledge, validation lifecycle expertise, data integrity assessment, deviation investigation, change control analysis, technical writing, statistical software analysis
Preferred skills
Sterile manufacturing experience, continuous process improvement knowledge
Technologies
MiniTab
Responsibilities
Review validation master plans, IQ/OQ/PQ protocols, cleaning validation, and computerized system validation packages; verify data integrity and acceptance criteria; assess deviations and change controls; support cross-functional teams in resolving documentation gaps; maintain document review checklists and templates.
Seniority
Mid-level, hands-on IC
