stillingsbetegnelse:
Qualified Persons delegate for clinical trial products

jobbeskrivelse:
- Quality - Denmark - Måløv Do you see yourself contributing to maintain the high level of quality we strive for everyday? Do you want to be part of upholding our excellent compliance level when we label and pack products used for all Novo Nordisk clinical trials globally? Can you be an Excellent Quality Professional? If this is you, then we have the job for you! About the department You will join our department which consists of 22 dedicated colleagues; we are a part of the Chemistry, Manufacturing and Control (CMC) Quality Assurance organisation. Our responsibility is to ensure that all QA activities required by the GMP laws and regulations related to Investigational Medicinal Products are fulfilled. Our primary internal stakeholder is the area that is responsible for labelling, packaging and supplying for clinical trials worldwide. 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. The position The organisation’s continuing high level of compliance and inspection readiness is on top of your agenda. Your main focus will be split in two: As QP delegate you will certify final packed product for use in clinical trials world-wide. Besides this you will work with quality tasks related to the clinical packaging facility in Måløv. Together with a small group of colleges, you will the primary point of entry for activities related to approval of procedures, change requests and non-conformities from the clinical packaging facility. You will also be involved in QA Approval of documentation related to the facility. You will conduct formal and informal Quality Oversight and play an active role in solving challenges with quality aspects. You will furthermore provide ad hoc quality support for long term development of our business and its quality system. Here you will utilize your knowledge about Novo Nordisk and authority regulations and requirements in order to solve our challenges. You can look forward to entering into an energetic and positive working environment where cooperation amongst highly professional, 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 you for acting as a QP according to European legislation. Please refer to Vejl-QP-08 at laegemiddelstyrelsen.dk. The preferred candidate has experience working in a GMP packaging facility or as QA for a packaging facility and has acted as a QP or QP delegate. 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 master efficient communication, decision making and keeping cool even in tense situations - always focusing on never compromising on quality. In quality related issues you take charge and set direction to ensure timely resolution. For more information please see link: http://www.novonordisk.com/cmc-careers Working 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 August 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