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Operations Lead

Manufacturing / Production
Dublin South
Danielle Francois
Temporary
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Job Reference: JO-2011-65486_1606733155

Summary:

Our client, a leading pharmaceutical organisation based in South Dublin are recruiting for an Operations Lead for a long term contract role.



The Operations Lead will serve as the primary production process owner responsible for New Product Introduction and Life Cycle Management Projects and process improvements projects.




* Function as the site interface between the Product Delivery Teams (PDT's), and ADL Manufacturing operations.


* Develop, review and approve generic 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 process/project


* Evaluate, plan, and implement solutions for process improvement opportunities


* Support scheduling and execution of Characterisation, Engineering and PPQ runs including 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 behaviours within Product team


* Perform Job Hazard Assessments and Change Control Assessments to determine impact to Manufacturing


* Partner with Learning & Performance to define training strategy's for NPI's and complex projects


* Liaise 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


* Liaise with Process Development regarding process changes in an effective and timely manner


* Own and lead change controls as required by the NPI Project Team


* Review and approve bills of materials


* Develop, review and update Product Quality Risk Assessments



Relevant Experience:


* Bachelor's degree in a science discipline.


* 2+ 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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Danielle Francois
Danielle Francois
Senior Talent Consultant
Supply Chain
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