OrganOx
Organ technology
TechnologyTransferEngineer
“Technology Transfer Engineer at OrganOx. Skills: Technology transfer, Change control, Project management, Regulatory compliance. Create Change Controls. Present at CC Review Board”
What You'll Achieve.
Deliver company change projects; Ensure continuity of supply; Deliver results on time; Deliver within scope
Industry & Context.
Root Cause Analysis; Issue resolution; Evaluate technical issues; Simplify technical issues
Occasional travel, Travel to supplier sites, Travel to CDMO sites, Travel outside UK
What You'll Do.
Create Change Controls
Present at CC Review Board
Complete CC activities
Ensure successful roll out
Perform seamless updates
Ensure regulatory compliance
Ensure continuity of supply
Deliver end-to-end project management
Ensure process validations completed
Ensure equipment qualifications completed
Ensure method changes completed
Create Specifications
Review Specifications
Create Standard Operating Procedures
Review Standard Operating Procedures
Create Work Instructions
Review Work Instructions
Execute validation protocols
Execute qualification protocols
Assist with Root Cause Analysis
Support risk assessments
Support mitigation strategies
Support issue resolution
Provide project status updates
Provide mitigation strategy updates
Ensure activities align with standards
Support regulatory submissions
Support documentation
Collaborate with Quality Assurance
Update quality systems
Contribute to Health requirements
Contribute to Safety requirements
Contribute to Environmental requirements
Contribute to Sustainability requirements
Assist with general duties
Ensure adherence to Code of Conduct
Ensure adherence to company policies
How You'll Work.
Team & Collaboration
Cross-functional teams; External partners; Quality department; Project stakeholders
Communication Scope
Verbal communication; Written communication
Process & Methodology
Project management, Change management, Risk management, Planning, Execution, Reporting
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