Operations Lead

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.

Fastnet has a strict confidentiality policy - please be assured that your details will never be forwarded to any third party without your consent.

Fastnet - The Talent Group
'Not Just Placers.........Partners'

The Life Science Specialists