Clinical trial set-up, packaging, labelling, storage & distribution projects.Importation and release of IMPs into the UK, GB QP oversight studies, EU clinical studies

Technical transfer of new commercial and clinical projects coming into the operational group from either formulation development or external clients in accordance with cGMP. Writing technical / quality specifications, master batch records for manufacturing and packaging, material specifications and BOM’s. Interpretation of clinical trial protocols and development of cost effective and compliant packaging solutions. Identify continuous improvement opportunities to improve operational… Show more Technical transfer of new commercial and clinical projects coming into the operational group from either formulation development or external clients in accordance with cGMP. Writing technical / quality specifications, master batch records for manufacturing and packaging, material specifications and BOM’s. Interpretation of clinical trial protocols and development of cost effective and compliant packaging solutions. Identify continuous improvement opportunities to improve operational efficiencies. Write GMP documentation and provide technical support to internal department and external clients. Show less

Management of multiple clinical trial supplies projects for a variety of external clients. Lead internal project teams throughout the project lifecycle from initiation, execution, through to close down. Responsibilities included the generation of project plans, budget management, writing technical documentation. Principal point of contact for the client, and communication of project status via reports and miinutes, teleconferences and face to face meetings.

Inventory management of starting materials, intermediates and API using a MPS to define manufacturing schedules by third party suppliers.

Processing of case report forms and electronic data via the clinical database. Review of database entries and the generation of queries to investigators to clean the databases of anomalies. Worked in accordance with GCP.