stillingsbetegnelse:
Quality assurance scientist within pharmaceutical development

jobbeskrivelse:
- Research Scientist - Denmark - Måløv Do you have a strong quality mindset, the right knowledge and experience it takes to secure and drive the quality within a department and area that develops the diabetes products of the future? If so, you have the opportunity to play a key role in CMC Diabetes Formulation Development in Måløv, Copenhagen. As the link between the research unit and the production we are responsible for developing formulation and processes for new diabetes products – all the way from early development to phase III clinical trials and registration. About the department We are organised in two formulation teams and a small group of drug product coordinators. The department has a total number of 43 persons. Team 1 is responsible for early stage formulation and process development as well as biophysical characterisation of the protein formulation throughout all clinical phases. Team 2 is responsible for late stage development including both product and process development from phase 3 clinical trials until submission to health authorities. Both teams handle documentation of product and process development including GMP stability and clinical trial documentation. You will be part of one of the teams and you will work in close collaboration with the department QMS assistant. The job You will be the driver of new and existing quality initiatives in the department and VP area, working both within the department and also on a cross-organisational level. Your main responsibilities will be driving initiatives related to Quality Management and implementing corporate quality initiatives both within the department and across the VP area covering 3 different formulation development departments; handling non conformities through systematic problem solving (A3); arrange and head up departmental GxP-days; bridge between department and Quality Assurance; provide sparring to department manager, research scientists and QMS assistant; Establishment of training plans for new employees; Review relevant new standard operating procedures and guidelines Together with your colleagues you will contribute to the on-going optimisation of processes and systems with LEAN as the guiding light. The goal is clear: Secure high quality and compliance during development of the next generation of products for diabetes treatment. Qualifications You hold a M. Sc. within Pharmacy, Engineering or related field of study backed by a minimum of 2-3 years’ of practical experience within QA, QC or related field of the pharmaceutical industry. It is an advantage if you have experience with quality aspects of R&D projects. As a person you possess drive and a positive mind-set, and you strive to be in a decision-making role. When cooperating you often take the leading role and you enjoy setting direction to others. At the same time you also thrive on being the inspirer and guide to your colleagues. At Novo Nordisk, we create value by putting patients first. Every ten seconds two people are diagnosed with diabetes, and more than 371 million people worldwide need us. Working here is not just a way to make a living, but a way to make a difference. Contact For further information, please contact Annette Midtgaard Hvilsom at +45 3079 3461(week 32/33/34). Deadline 28 August 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark