Analista de Validação Pl e Sr
Core
Develop and execute equipment/utility qualification and computerized system validation documentation and protocols for pharmaceutical manufacturing units.
Role type
Validation and Qualification Analyst (Junior to Senior)
Builds
Qualified equipment, validated systems, and compliant manufacturing processes
Domain
Pharmaceutical manufacturing (solids, liquids, semisolids, injectables)
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Equipment qualification, system validation, risk analysis, URS creation, traceability matrix development, deviation analysis, SOP writing
Preferred skills
Knowledge of GMP and GLP regulations
Technologies
Office suite
Responsibilities
Develop validation documentation (Validation Plan, URS, Risk Analysis, QP/QI/QO/QD, Traceability Matrix), execute qualifications and validations, review qualification reports and computerized systems, evaluate protocol results and deviations, create and review operational procedures
Seniority
Junior to Senior, hands-on IC
