Operations Lead

Operations Lead

Team Horizon is seeking a Operations Lead for a pharmaceutical client in Dublin. The Operations Lead will serve as primary production process owner responsible for New Production Introduction, lice cycle management projects and or CAPEX projects and established process improvements projects.

This role requires in depth technical and operational knowledge of aseptic drug product manufacturing processes; parts/ components preparation, formulation, syringe filling, vial filling, lyophilisation and capping.

Why you should apply:

• This is an excellent opportunity to join a world class manufacturing operation, with an outstanding track record of reliably delivering high-quality medicines to patients around the world suffering serious illnesses.
  
  
• There is a strong culture of continuous improvement and innovation within the company to strive for solutions that improve health outcomes and dramatically improve people’s lives.
  
  
• Our client is developing the capability to produce all its medicines in Dublin, helping to ensure continuity of supply of our medicines as they expand internationally.
  
  What you will be doing:
  
  
• Function as the site interface between the Product Delivery Teams (PDT’s), and ADL Manufacturing operations.
  
  
• Engaging with staff members within the Manufacturing department to ensure understanding of the processes and working collaboratively cross functionally with Facilities & Engineering, Quality, PD and Supply Chain.
  
  
• Develop, review, and approve Generic Master Batch Records and Parameter Value Lists across Formulation, Filling and Inspection.
  
  
• Develop, review and update Production, Engineering, Operating Procedures & training materials
  
  
• Assist in providing training on scientific or technical aspects of the current process/project(s) to Direct Manufacturing.
  
  
• Evaluate, plan, and implement solutions for process improvement opportunities both current and project related.
  
  
• Support scheduling and execution of Characterisation, Engineering and PPQ runs, ensuring all necessary pre-requisites are included on the schedule and assess process performance by observation of floor operations and review of performance data
  
  
• Provide troubleshooting support throughout the project and on the floor during execution of activities
  
  
• Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing.
  
  
• Partner with Learning & Performance to define training strategies for current processes, NPIs and complex projects.
  
  
• Consult with Quality Assurance to ensure that GMP standards are maintained in line with current SOP’s, batch documentation and licence.
  
  
• Develop, review and update Protocols for manufacturing activities.
  
  
• Documentation and approval of protocol deviations for manufacturing activities
  
  
• Consult with Process Development, Direct manufacturing, Equipment, and System Owners regarding process changes in an effective and timely manner
  
  
• Own and lead change controls as required by the Manufacturing support team
  
  
• Review and approve Bills of Materials.
  
  
• Develop, review and update Product Quality Risk Assessments.
  
  What you need to apply:
  
  
• Strong Project Management and organizational skills, including ability to follow assignments through to completion
  
  
• Critical thinking skills: Gathers data from key stakeholders, analyses and interprets information to develop solutions to technical problems of moderate complexity
  
  
• Negotiation and Influencing skills
  
  
• Take initiative to identify and drive improvements
  
  
• Excellent verbal and written communication skills: Strong Technical writing skills for GMP documentation (e.g., investigations, procedures, change controls) and good Presentation skills
  
  
• Escalate issues professionally and in a timely manner
  
  
• Decision Making skills and confidence to challenge others on decisions that impact the manufacturing area