Stephen Cook Email & Phone Number

Responsible for product packaging design and technical specifications creation and improvements for commercial development and prototype design. Support technology transfer by leading qualification and validation activities for new products/tooling and materialsContinuous improvement of processes, operations and systems. Accountability for product packaging design and technical specifications, to include commercial, development and prototype design.Responsible for generation of packaging related technical documents and reports, such as process technical trials, qualification and validation, Pack Families, technical drawings and SAP Master Data. Provide technical support and guidance to production and third party operations.Applies Good Manufacturing Practice in all areas of responsibility and ensures activities are carried out in accordance with the requirements quality systems, GMP Guidelines and Industry Standards. Leading and supporting deviation investigations, corrective action and preventative action (CAPA) implementation and customer complaints reporting.

Hatfield

- Develop Good Manufacturing Practice (GMP) documentation including SOPs, forms and reports.- Ensure the Eisai Validation Master Plan (VMP) and product Validation Plans are compliant & kept up to date.- Review & identify new products or components that require Process Validation (PV) or Cleaning Validation (CV) activities. - Review & approve qualification & validation protocols/reports to ensure compliance with Eisai’s VMP, Standard Operating Procedures (SOPs) & Quality Management System (QMS) - Raise deviations, & implement Corrective & Preventative Actions (CAPAs), as required in Trackwise.- Develop and successfully execute manufacturing & packaging cleaning validation protocols/reports.- Act as quality representative and provide support for key manufacturing/packaging projects including: New Product Introduction (NPI), Introduction of new blister packaging lines / vial line, Facility expansion including HVAC & EMS modifications, Electronic Systems (SAP workflows, Trackwise workflows & DMS).- Provide qualification & validation training, as required.- Support the coordination of local/global Change Controls & Action Items.- Support Internal/External audits including FDA & MHRA.- Provide regulatory support for NPI & existing regulatory filings.

Welwyn Garden City

- Author & approve global/local Good Clinical Practice (GCP) documents including Standard Operating Procedures (SOPs), forms & supporting documents for regulatory compliance in the Quality Management System (QMS).- Support the processing of UK GCP affiliate deviations and CAPAs- Liaise with the training department to maintain training matrix for issued & upcoming documents.- Assist the GCP Compliance Manager with audit plans from external agencies (FDA, MHRA etc) & ensure all Trial Master File (TMF) documentation is prepared prior to an inspection. - Ensure key regulatory documentation (Investigator Brochures, Clinical Study Protocols & local Safety case coding guidelines) are maintained & available in the eTMF Information repository.

Welwyn Garden City

Welwyn Garden City

Diploma, Packaging Technology, Merit

Bachelor'S Degree, Computer Science