stillingsbetegnelse: Quality Assurance Professional

jobbeskrivelse:
- Quality - Denmark - Måløv Quality Assurance Professional for QP release of Investigational Medicinal Products, CMC Clinical Supplies QA.Do you see yourself contributing to high quality and compliance of products used for Novo Nordisk clinical trials globally? About the department You will be part of a dedicated department of 22 colleagues located in Måløv. We are part of the CMC Quality Assurance organization, which is responsible for all QA activities required by the GMP laws and regulations related to Investigational Medicinal Products used for the increasing number of Novo Nordisk clinical trials globally. We work with GMP at the borderline of GCP and see ourselves as key players in the success of the growing portfolio of Novo Nordisk clinical trials. We are looking for a new colleague to support the quality activities in this Clinical Supplies part of the Novo Nordisk R&D organisation. The position is to be filled as of march 1st 2016 The job The organization’s continuing high level of compliance and inspection readiness is on top of your agenda. You will be responsible for quality assurance of activities and documents related to the labelling, packaging and supplying of product for Novo Nordisk trials globally. You will review and approve procedures, change requests and cases of non-conformities, customer complaints and other documents related to the packaging, release and distribution of trial product. As a Qualified Persons delegate you will certify final packed product for use in clinical trials world-wide. You will provide quality support to our internal stakeholders where your ability to apply Novo Nordisk and authority regulations and requirements is key to solving challenges in both daily operation and long term development of the business and its quality system. You will interact with colleagues across the CMC Supply organisation and also with colleagues from other parts of Novo Nordisk A/S both in Denmark but also with affiliates world-wide. You can look forward to entering into an energetic and positive working environment where cooperation amongst highly engaged and dedicated Novo Nordisk colleagues is key to your and the company’s success. Qualifications Your approach to this position is a master’s degree as a Pharmacist or other master’s degree qualifying for acting as a Qualified Person. The preferred candidate has several years of experience working according to GMP requirements (production/QA) in a pharmaceutical business with a manufacturing authorization from DHMA (§39) and has acted as a Qualified Person or delegated Qualified Person. Direct experience with certification of product and GMP work related to clinical trials should be highlighted in your application as this will be weighted highly when evaluating applicants. On a personal level, you demonstrate engagement, credibility and empowerment. You like a professional and dynamic environment with many simultaneous tasks and changing priorities. You are aware of how to apply an excellent QA behavior. You master efficient communication, decision making and keeping cool even in tense situations - always focusing on never compromising on quality. Feel free to submit your job application in either English or Danish, whichever you prefer. Also please share this add with friends and professional connections you might think would be interested in pursuing this career opportunity at Novo Nordisk. In Novo Nordisk it is your skills, your commitment and your ambitions, which helps us to improve many people's lives. In return we offer you the opportunity to work with exceptionally talented colleagues, and we offer you a wide range of opportunities for professional and personal development. Contact For further information please contact Birthe Boldvig Rottwitt at +45 3075 0158. Deadline 15 January 2016.

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