Conni Juhl

11 years experience from NN BioPharm Aseptic Filling Department, within Environmental Monitoring, GMP, formulation and aseptic processes in Aseptic Areas. Good training skills of people working in Aseptic areas. Participated in several GMP Audits and FDA Inspections. 7 years experience within computer validation and GxP compliance experience within NN for an GxP critical IT system as Advanced Business Analyst at Novo Nordisk. Experienced within ITIL processes and process optimization as responsible for the preparation of the standard operating procedures (SOPs) for Master Data and processes for NN System PEMS. Certified in ITIL Foundation v. 3. Experienced as ITQA in review of validation documentation such as Quality Plans, Validation Plans, Requirement and Design Specifications, Installation/Operational/Performance Qualification protocols and reports as well as performing tests in TIMS as to be ready for presenting data or methods during audits and inspections. Experience with TIMS (Test Information Management System) as test management tool. Testing and documentation is performed based on GAMP5 and FDA compliance. Other qualifications: 7 years Training management skills, in IT System for Production and QC. Skills in both preparing Training Material and skills in use of “Herskin” Training method. Training skills in both Danish and English. Project Management skills. Participated in several minor and some large projects in UpGrade of IT Systems.