Operations Lead

4 weeks ago

Dublin, Ireland TEAM HORIZON Full time
Description

Team Horizon is seeking an IE CW Operations Lead for our client based in Dublin. The Operations Lead will serve as primary production process owner responsible for New Product Introduction, Life 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.



They will be the operations point of contact for coordination of the manufacturing effort and will be responsible for driving process efficiencies as part of the project for operations.


They will apply process, operational, scientific expertise, basic compliance knowledge, and analytical and troubleshooting skills to ensure streamlined manufacturing operations are enabled in both vial and syringe facilities.



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
Hold people to account for delivery and behaviors within the Manufacturing Support team and associated with the project(s)
 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 licences
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. 
Teamwork and Coaching others .
Ensures compliance within regulatory environment. 
Demonstrated ability to work independently and deliver right first-time results under minimal direction .
Bachelor’s degree in a science discipline. 
3+ years of biopharmaceutical manufacturing experience in Fill Finish or related manufacturing or GMP experience in the pharmaceutical or medical device industry. 
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products.

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