Validação de Sistemas
Core
Ensures compliance of computerized systems and processes in regulated life sciences environments through validation lifecycle management.
Role type
Senior Computerized System Validation (CSV) Specialist
Builds
Validated computerized systems and processes for pharmaceutical, medical device, food, and cosmetic industries
Domain
Life Sciences / Regulatory Compliance / Quality Assurance
Deliverable
production ML models | product features | dashboards & analysis | client delivery
Required skills
GAMP 5, validation lifecycle (URS, FRS/DS, IQ, OQ, PQ), 21 CFR Part 11, EU GMP Annex 11, RDC ANVISA, risk management (FMEA), change control, deviation/CAPA management
Preferred skills
Six Sigma, ISO Lead Auditor, ERP/LIMS/MES/QMS systems, regulatory audit/inspection experience
Technologies
GAMP 5, ERP, LIMS, MES, QMS
Responsibilities
Execute validation protocols and documentation, manage risk assessments, oversee change control and CAPA, prepare for regulatory audits
Seniority
Senior, hands-on IC