Sr. Process and Systems Optimization Specialist

Há 1 mês


Rio de Janeiro, Brasil Thermo Fisher Scientific Tempo inteiro

Review, monitor and approval of controlled process documents for quality, compliance, and commitment gaps, in co-ordination with Sub Process Owners (SPOs) or Process Owners (POs) - Compliance Support - Review, assess, monitor and approve process deviations - Lead investigation and assist in Root Cause Analysis of Quality Issues (QI) and CAPA - Review and approve QualityIssues (QI) - Assist the CAPA owner in performing Root Cause Investigations, review and approve CAPA actions - Monitor CAPA to completion - Audits and Inspections
- Pre-Inspection Support
- Inspection Readiness Training - Mock Interview sessions - Pre-Inspection Doc request and review - During Inspection support
- Co-host/Host - Inspection Doc Request support - Control Room support - Post-Inspection Support
- Lead CAPA plan completion - CAPA Monitoring to Completion - Ensure R&D Quality Management System maintenance in the Affiliate Medical Teams



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