THE QUALITY AUDITOR ANALYTIKEREN 1 ENSURES THAT GARANT FOR QUALITY IS OF THE FORBRUGERNES SIKKERHED HIGHEST ORDER DITOR THE QUALITY AU When laboratory technologist, Susanne Jeppe sen, is doing her job at Novo Nordisk A/S in Bagsværd it is done for the most part at a desk and in front of a computer screen. With 36 years of laboratory experience she has chosen to put work in the laboratory behind her. Instead her job is now to check that her colleagues comply with GLP Good Laboratory Practice. Susanne Jeppesen is a quality auditor along with seven others in the GLP QA department at Novo Nordisk A/S. It is Susanne and her seven colleagues who ensure that the quality of the GLP trials which are undertaken at Novo Nordisk A/S meet the requirements in force. Our most important task is to ensure that quality is of the highest order, so that in the end the patient gets the best medicine. That is the banner headline for our work, says Susanne Jeppesen. In our daily work we can sometimes be regarded as a kind of policeman who is looking over your shoulder. Because we do go checking that things are being undertaken as they should be. Our most exclusive task is just this, that if there are errors and shortcomings, then we find them. It is the way we try to ensure that quality is of the highest order, that everything meets the different regulations, says Susanne Jep pesen. Laboratory Technologist since 1980 She has been a laboratory technologist since 1980, for the most part in different microbiological laboratories. In 2008 she chose to drop the work in the laboratory for work at a desk, where she spends more than 80% of her work6 ing time. The rest of the time is spent monitoring and checking in the laboratories. She choose to move to quality auditor work because she thought she needed new challenges. It can become a little humdrum in the long run working in a laboratory. Work as a quality auditor is very varied and independent. We have a big responsibility and a very stimulating job. In the process we must make many decisions and take a position on different issues, which we get from internal customers we have in the company. There is also the advantage with the job that you become good at English because the vast part of our work takes place in that language. All the material we look through is in English. Outwardly we have also got many contacts because we visit many departments and examine different analyses, she says. When you start in the GLP QA department you have to attend a range of internal and external courses. Susanne Jeppesen was amongst other places sent to England to attend some GLP courses. We don t have many courses like that in Denmark. The work is like this Novo Nordisk A/S is continually running a large number of pre-clinical trials and GLP QA checks that the trials meet the requirements for Good Laboratory Practice. Tests are carried out on mice and rats, and all the trials are necessary before the medicine is tested on human beings. It is these trials that Susanne Jeppesen and her colleagues are examining and checking whether the regulations have been complied with. The work as a quality auditor is very varied and independent Prior to each separate GLP study a study plan is drawn up by a so-called quality control coordinator. Often it is about analyzing blood samples from mice and rats which have been tested primarily for insulin preparations. The GLP QA also checks that the laboratories meet the Danish authorities' requirements (Danish Medicines Agency) and comply with OECD regulations. The OECD requirements are a European code of practice, which have been directly drawn up with a view to GLP work. Checking raw data When the trials have been concluded in the laboratory, a report is produced in English. During the trial a lot of data has been generated. This data is raw data which the laboratory technologists have noted down during the trial in the laboratory. This raw data is collected in a file which is received by the department. We then look through this data and it is a large part of my daily work to check whether the trials meet the requirements and that all the papers have been filled out which they have to be according to good documentation practice. Finally, I complete my work by drawing up an audit report which describes whether everything is in order, or whether there are perhaps some errors or shortcomings which will have to be corrected. The report is then sent to a quality control coordinator/or occasionally to an outside quality control coordinator, and he/she corrects the errors if there are any, says Susanne Jeppesen. n 7 MEET 9 SPECIALISTS WHO ARE CREATING THE FUTURE THE DEV ELOPER THE IT SUPER USER DITOR THE QUALITY AU THE TECHNOLOGIST THE COORDINATOR THE LOGISTICIA N THE ANALYST THE TRAINER LABORATORY TECHNOLOGIST EDUCATION THE WORLD CITIZEN CONTENTS A PROFESSION UNDERGOING CHANGE In Dansk Laborant-Forening/HK (DL-F) we know that our profession contains a vast number of exciting job opportunities. 03 Preface: A profession undergoing change 04 The Analyst: Guarantor for consumer safety 06 The Quality Auditor: Ensures that quality THE ANALYST ANALYTIKEREN 1 GUARANTOR GARANT FOR FOR CONSUMER SIKKERHED FORBRUGERNES SAFETY THE ANALYST Eva Jørgensen has been a laboratory technologist since 1989 and has worked at the Danish Veterinary and Food Administration's laboratory in Ringsted since 2006. At that time, she was, together w THE QUALITY AUDITOR ANALYTIKEREN 1 ENSURES THAT GARANT FOR QUALITY IS OF THE FORBRUGERNES SIKKERHED HIGHEST ORDER DITOR THE QUALITY AU When laboratory technologist, Susanne Jeppe sen, is doing her job at Novo Nordisk A/S in Bagsværd it is done for the most part at a desk and in front of a compute IT SUPER USER BRIDGE-BUILDER BETWEEN RESEARCH AND IT DEVELOPMENT Since Mads Molich completed his education as a laboratory technologist in 2006, he has for the most part not had two working days that are the same. Today he works at Novozymes A/S in Bagsværd as a scientific laboratory technologist o THE COORDINATOR FLAIR FOR ORGANISING AND GATHERING KNOWLEDGE THE COORDINATOR As a working environment and emergency and security coordinator Henriette Lerche no longer works in the laboratory. Her workplace is the long corridors and offices at the Niels Bohr Institute at Copenhagen University on THE LOGISTICIAN SAY WHAT YOU NEED AND I'LL GET HOLD OF IT Laboratory technologist Heidi Irming is a buyer at DTU Biosustain, Novo Nordisk Foundation Center for Biosustainability (CFB) in Hørsholm. She has recently been extremely busy in connection with the moving of DTU Biosustain to a completely THE TRAINER ANALYTIKEREN 1 THE LABORATORY TECHNOLOGIST TEACHES THE DOCTORS OF THE FUTURE Thousands of young medical students have over the years become acquainted with Helle Dyhrfjeld Jensen's professional guidance in the laboratories of the Panum Institute in Copenhagen. Helle is employed as a pr THE DEVELOPER I LEARN SOMETHING NEW EVERY DAY Lene Odgaard Kamstrup is a laboratory technologist with the Danish-American company CMC Biologics A/S, CMC, in Søborg. The biotechnology company is a customer-based company. This means that they have many different customers which they undertake develop THE TECHNOLOGIST FROM ALARM CLOCKS TO ROBOTS Inge Lise Stripp Petersen has always enjoyed technology, IT and programming. Since she was little she has taken everything apart from alarm clocks to sewing machines. Today she is a laboratory technologist at Novo Nordisk A/S in the API Bio Analysis depa THE WORLD CITIZEN I participate in weekly Skype meetings with the Indian and Polish development departments ALL-ROUND JOB WITH AN INTER NATIONAL PROFILE Weekly Skype meetings with Indian engineers, visits to factories in Germany, France and India, courses in England and meetings with Japanese cust WORTH KNOWING ABOUT THE GENERAL EDUCATION SYSTEM WORTH KNOWING ABOUT FURTHER EDUCATION & TRAINING In Dansk Laborant-Forening/HK(DL-F) we are working on creating a transparent way through the education system. It can be in relation to mem bers, employers as well as the political system. In Dansk L ABOUT DANSK LABORANTFORENING/HK (DL-F) Dansk Laborant-Forening/HK (DL-F) is a cross-union association in HK. We organize approx. 10,000 members whose primary educational background is laboratory assistant, laboratory technologist, environmental engineer or environmental technologist; they are employ