Lars Jakobsen

Background

About Lars Jakobsen

Chemical Engineer currently employed as Principal Specialist within qualification of suppliers, contractors and contract laboratories. Broad experience from industry in general and especially from the pharmaceutical industry.Responsible for external auditing of suppliers and contractors.Design of supplier qualification program.Experience with basic and detailed design of manufacturing facilities, setting user requirement specifications for equipment, equipment qualification, process validation.Experience in compliance and quality issues on computer systems validation, equipment and support systems qualification, evaluation and approval of both equipment and raw material suppliers, including packaging material suppliers.Focus on Continous Process Verification, Manufacturing Intelligence and Product Quality Review.Working with quality issues of product development, technical transfer and process development.Fluent in english.Specialties: Supplier qualificationExternal auditingEquipment QualificationComputer Systems ValidationContinuous Process VerificationSupply Systems QualificationProject ManagementBasic Factory DesignDetailed Factory DesignSupplier Qualification Experienced Raw Material Supplier AuditorExperienced Equipment Supplier AuditorQA appointed Lead AuditorExperienced Packaging Material Supplier AuditorIRCAN Certified ISO Quality Systems AuditorAPIsRaw MaterialsPackaging MaterialsSetting and maintaining proper material specificationsCompendial complianceProcess ValidationExperienced in FDA Pre-Approval InspectionsImplementation of EDMS and Workflow SystemsPrinting technologies (Flexo, DoD)Ink Migration