QMS Specialist - Solid Dosage Forms

Aufgabenbereich:

- Quality - Denmark - Måløv 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 manufacturing capacity and are establishing a new tablet and packaging facility. 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 DP Launch Plant is newly established project organisation. The purpose of the department is to establish a new manufacturing facility for production and packaging of tablets. This means qualifying the manufacturing equipment, setting and validating the manufacturing processes are key deliverables. The Job Overall you will play a key role in establishing the Quality Management System (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 new production facility is qualified to fulfil all authority requirements and ensure timely dialog with the regulatory affairs or the authorities. The job involves setting of quality goals for the department and performing training of employees. Corporation with quality specialists across Novo Nordisk 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 market production of drug products 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 contact Peter Langkilde Sonne at +45 3079 8415 or Peter Søtofte Elten at +45 3079 8453. Deadline 13 February 2016.

Arbeitszeit:

• Ohne Arbeitszeitbestimmung
  

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source: https://www.ec.europa.eu/eures

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