stillingsbetegnelse: QMS Specialist

jobbeskrivelse:
- Research & Development - Denmark - Måløv Our growth is your opportunity Being part of Novo Nordisk Research & Development means working at one of the world's largest and most successful biopharmaceutical companies. Our R&D organisation is vital to Novo Nordisk's continued growth and we always welcome talented people who would like to grow with us. Are you ready to take up new complex quality challenges? As Novo Nordisk is developing break-through oral formulations of insulin and GLP-1, we are expanding our clinical late phase organisation. That is why we are looking for a quality specialist, who can set direction in the borderline between development and production. You will take responsibility for the quality management system ensuring that the department and its deliverables are ready for inspection from authorities and internal quality entities. About the department Oral Protein Manufacturing Development is newly established. During the next half year we are expanding from 22 to app. 85 employees. The purpose of the department is handling late stage clinical trial and preparation of filing documentation. This means qualifying the manufacturing equipment, setting and validating the manufacturing processes are key deliverables. Also the department will be responsible for operating the late phase facility. The job Overall you will play a key role in establishing the QMS for the department. Furthermore you will advise and help your colleagues working in compliance i.e. when performing a risk assessment or test plan for process validation. You will ensure that the late phase production facility is qualified to fulfil all authority requirements and ensure timely dialog with the registration department or the authorities. The job involves setting of quality goals for the department and performing relevant training of employees. Corporation with quality specialist from Product Suppy will be a major task to ensure right interpretation of latest internal and external quality standards. Qualifications You have a Master degree in Pharmacy, Engineering or a related field and at least 5 years of experience from the pharmaceutical industry, where you have gained solid experience within QMS and GMP standards for late stage development and filing for authority approval. Knowledge or experience with equipment qualification or computer validation compliance would be preferred. First and foremost you have an excellent quality mind set, strong communicational skills and you can place the importance of compliance on the agenda in a positive and constructive way. As a person, you are known for a high commitment to finding constructive solutions as well as taking responsibility for your assignments. You have a good overview, a structured and dedicated way of working and the ability to balance when to compromise and when to stand firm. At Novo Nordisk we use our skills, dedication and ambition to help people with diabetes and change their lives. By working with us you will have the opportunity to do the same in a global business environment. Contact For further information please call Peter Langkilde Sonne on +45 3079 8415 or Rikke Schnipper on +45 3075 5797. Deadline 26 November 2014.

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