Responsable Validation Analytique - Laboratoire Analytique F/H
Core
Supervise analytical validation operations, investigations, and laboratory compliance with GMP and quality control processes within a pharmaceutical quality control laboratory.
Role type
Senior IC analytical validation manager
Builds
Validated analytical methods, qualified equipment, and compliant laboratory operations
Domain
Pharmaceutical industry + analytical chemistry/quality control
Required skills
Analytical validation, GMP compliance, laboratory equipment qualification, CAPA management, OOS/OOT investigation, team leadership, change control, risk identification, KPI tracking
Preferred skills
Continuous improvement initiatives, regulatory inspection support, investment project management
Technologies
GMP, BPX, CAPA, OOS, OOT, change control systems
Responsibilities
Supervise analytical validation operations and investigations, ensure laboratory compliance with GMP and quality processes, qualify and train laboratory personnel, maintain and calibrate laboratory equipment, contribute to trend data and risk identification, define and execute validation/transfer protocols, evaluate validated method status, conclude stability testing controls, support complex quality investigations (OOS, OOT, deviations), prepare for regulatory inspections and audits, establish performance indicators and KPIs
Seniority
Senior, hands-on IC
