Operations Lead
Amgen
Total years of experience :7 years, 3 Months
Responsibilities:
• Primary Production Process Owner Responsible for New Product Introduction (NPI) and Life Cycle Management (LCM) and process improvement projects
• Develop, Review and Approve generic batch records and parameter value lists across Formulation, Filling, and Inspection
• Evaluate, Plan and Implement Solutions for process improvement opportunities
• Own and Lead Change Controls as required by the NPI Project Team
• Liaise with Quality Assurance (QA) to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licences.
• Program Manager to Cross Functional Manufacturing Program
• Develop, review and update Product Quality Risk Assessments
• Assist in the discovery, development and implementation of continuous improvement ideas found during the NPI and LCM process
Responsibilities:
• Designing/Writing SOP’s
• Project Manager Asia-Pacific (APAC) Artwork Internal Audit
• Cross Functional Team Representative for APAC Region Artwork Review
Responsibilities:
• Data Driven Project Facilitation and Process Development within Operations Units
• Project Management of Departmental Initiatives in Upstream/Downstream and Raw Materials Units
• Cross Functional Support to Site Supply of Raw Materials
• Cross Functional Team Lead of Culture and Data Integrity (DI) Projects
• Lean Six Sigma Greenbelt: Programme Manager to Capacity Increase to Raw Materials Dispensing Unit to Support Site Wide Operations
• Change Control Facilitator for CMO Products as part of Project Management
• Liaising with Quality Assurance and Compliance on Improvements to GMP documentation
• Goal Setting/Driving Site and Departmental Goals
Responsibilities:
• Project Facilitation and Cross Functional Team Operations Subject Matter Expert (SME) of Site Wide Training Programme and Standard Work Initiative
• Developing, Reviewing and Implementing Process Protocols and Training Procedures for Increased Overall Equipment Efficiency (OEE)
• Responsible for Driving Key Performance Indicators (KPI) and Behaviours within the Operations Team
• Driving Right First Time (RFT) Practices through Training and Coaching on Troubleshooting GMP Documentation
Day to Day Process Activities
Level 9 NFQ Certificate in Creative Thinking, Innovation and Entrepreneurship. 3 Month Commercial Innovation Project with ESB, Ireland’s largest and main electrical provider. 3 Month Individual Innovation and Entrepreneurship Project to scope a Service or Product to demonstrate understanding of innovation frameworks and processes
Professional Diploma Change Management
Level 9 NFQ Certificate in Quality Assurance and Regulatory Affairs
Level 8 NFQ BSc in Pharmaceutical Healthcare