Global External Operations Specialist (GEO)

PSC Biotech is a leading Biotech Consultancy firm seeking a Global External Operations Specialist (GEO) to support biologics and small molecule drug product processing as well as finished goods packaging in Cork, Ireland. The successful candidate will have a minimum of 7 years' experience within an Operations and regulated environment.

Requirements

• Execute operational readiness requirements to enable CMO's to produce products
• Provide direct support to Process Team Leads across Commercial & Clinical products
• Manage and execute all transactional ERP aspects at production efforts at CMOs
• Own and manage prioritized change controls and deviations within the Quality Management System
• Consolidation and issuance of key performance metrics per Process Team
• Provide back-up support for Process Team Leads where necessary
• Support selected continuous improvement activities aligned to the site business plan objectives
• Work cross-functionally to perform rigorous root cause analysis, to understand issues and implement corrective actions as appropriate
• Document key business processes in a standard format