Operations Lead
Berkley Group
- Dublin
- Contract
- Full-time
- Function as the site interface between the Product Delivery Teams (PDT's), and 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
- 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.
professionals for organisations throughout Ireland; for more information go to www.berkley-group.comIf you would like to discuss this vacancy further or to discuss your career options in confidence, please contact Fred Chesne on +353 85 178 6539 or send your CV to fchesne@berkley-group.com.