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Job Summary: The student will be responsible for establishing, coordinating and implementing key technical support activities to Operations departments (Processing, Packaging, and Maintenance) and support for Pharmaceutical Development Services (PDS) Process Development department with new products that will be produced commercially at Whitby.
- To prepare or review procedures, protocols, batch records, documents and reports of the new product batches
- To support the shop floor in the scale up, feasibility, registration, validation and first commercial batches
- To help production staff with the processing difficulties
- External and internal client support ? assist in the coordination of project information between Business Management (BM), Technical Project Management (TPM), Quality Assurance (QA), Quality Control (QC) and commercial and PDS operations. Support TPM's with process execution and equipment trials. Perform batch analysis and trending
- Investigations and CAPA's
- Investigate and resolve process related issues
- Identify, propose and implement processes or equipment changes to solve quality problems, efficiency or regulatory compliance
- To take part in continuous improvement teams
- To review batch documents from PDS and recommend improvements for safe handling
- To keep updated with modern technological improvements in the processes and assist in the acquisition of new equipment
- To participate as team member on cross-functional teams, providing a technical vision
- Other duties as assigned
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