- Cordis (Irvine, CA)
- …R&D, Manufacturing and Supply Chain Applications. + Support On Site Subject Matter Expert (SME) with applications to ensure quality, compliance , and SLA/KPI ... business solutions under multiple deadlines. + Participate and provide GxP validation support during FDA Computer Software Validation activities **Qualifications**… more
- Ascendis Pharma (Palo Alto, CA)
- …submission and follow-up activities. Key Responsibilities Act as a Subject Matter Expert (SME) with regards to processing of Individual Case Safety Reports (ICSRs) ... (CAPA) as applicable. + Supports with the oversight of regulatory and departmental compliance by ensuring timely processing of ICSRs in the Safety Database and… more