Analytical Method Validation Specialist
Core
Coordinate and author analytical method validation activities to ensure GMP compliance and maintain the validated state of methods within pharmaceutical QC operations.
Role type
Analytical Method Validation Specialist
Builds
Validated analytical methods and quality documentation for pharmaceutical manufacturing
Domain
Pharmaceutical manufacturing / Quality Control
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Analytical method validation, GMP compliance, validation protocol authoring, validation report writing, risk assessment, change control management, deviation management, CAPA management, data analysis, stakeholder coordination
Preferred skills
French language proficiency
Technologies
None stated
Responsibilities
Author and maintain validation protocols, reports, amendments, and risk assessments; Coordinate validation studies and monitor experimental progress; Support quality events including deviations, change controls, and CAPA; Participate in peer reviews and investigations; Identify opportunities for process improvement
Seniority
Mid-level, hands-on IC
