Sr. Process and Systems Optimization Specialist - Rio de Janeiro, Brasil - Thermo Fisher Scientific
Descrição
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
- Cohost/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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