Bikrum Prem Email & Phone Number

Hertford, England, United Kingdom

Hertford, England, United Kingdom

Uk

Hurley, England, United Kingdom

Hurley, Uk

Royal Leamington Spa, Uk

Working as part of both Formulation & Quality teams for Boots Pharmaceuticals. Formulation OTC Medicines:Dealing with both NPD & EPD projects for the Healthcare team (GSL, P & POM medicines).Recent focus on leading and delivering formulation technical aspects of various projects for technology transfer of Licensed Medicines, working within cross-functional Meds Transfer team. Managing the delivery of key project milestones, leading on Formulation & Quality aspects, assisting with project management & global commercial sourcing activities. In brief duties include overall project knowledge/management, leading on technical issues. Authoring documents & checking/approving all aspects of manufacturing throughout the full life cycle of products. i.e. from lab scale, clinical trials, validation to routine production manufacture.Experience in many dosage forms, including sachets, medicated confectionary, liquids and various solid dose forms. Successful set up & managment of a new Technical Filing system for all licensed Healthcare products.Expertise in all aspects of licensed medicines development, tech transfer and manufacture (formulation, project management, regulatory & quality procedures etc).Quality Officer - Healthcare Team:Duties included working within team to set up new Healthcare Quality Management System. Dealing with various aspects to support the Quality Agenda, for licensed products; medical devices & other un-liscensed, cosmetic products. Technical Agreements expert.Assisiting project teams with quality issues associated with new development & tech transfer projects.Quality Audits of Boots contract service providers (CSPs) to ensure compliance to GMP, in house Quality standards & understanding our QMS. Assisting with management & approval of CSPs, monitoring compliance & any CAPA. Authoring, approving, training out SOPs to ensure wiser team compliance. Assisiting with requlatory authority & client audits.

Working within the Healthcare R&D Cold-Flu Formulation team. Dealing with both EPD & NPD projects for the Healthcare OTC branded products (including Strepsils, Lemsip & Nurofen brands).Focus on Cold Flu Formulation Innovation projects, experience gained in many formulation techniques, especially using medicated lozenge confectionary & sachet dosage forms. Working in full clinical & pilot units, GLP/GMP standards. Duties also included working within a team in order to set up the new Healthcare Stability Facility. Assisting with project managing the healthcare aspects of the change over to the new facility. Authoring & updating SOP's, protocols, training manuals etc. Assisiting with the set up of the new inventory system & overseeing the transfer of all samples & testing to the new stability suite.

Working within the Zydis New Product Development team.Formulation and Analytical Laboratory work.Experience gained in Zydis (fast dissolve/fast melt); suspension dosage; and other solid dose technologies. Following full GMP standards, GLP also used in experimental stages.Experience gained in many formulation, analytical & forensic techniques.