stillingsbetegnelse: Quality and Compliance Professional

jobbeskrivelse:
- Pharmacovigilance - Denmark - Bagsværd We are seeking a dedicated and ambitious colleague for our QA activities in Global Safety. Are you looking for a role where you can be part of a truly global workplace, where passion and engagement are met with opportunities for professional development? If you find this exciting and inspiring, you may be our new Quality and Compliance Professional, working with the rest of the team in securing the compliance to Quality and Pharmacovigilance requirements in Global Safety. The job You will be responsible for quality assurance activities in IT projects. This includes approval of change requests and validation incl. design and qualification steps. You will be responsible for assuring that the documentation is compliant with internal and external requirements. In close collaboration with your QA colleagues you will also be responsible for quality assurance activities required to meet pharmacovigilance regulatory standards in all areas of Global Safety, including related documentation such as non-conformities and change requests. Interaction with staff throughout Global Safety to ensure that the quality system is functioning properly and ensuring inspection readiness will be part of your day. You will be advising colleagues across all Global Safety areas and provide training, tools and techniques to enable others to achieve quality and compliance. Qualifications You hold a Master’s degree preferably accompanied with working experience in Quality Management Systems. The position requires significant insight into key IT processes, e.g. quality management, change and configuration management, IT security, risk management and testing. Furthermore, understanding of external requirements to IT validation in the pharmaceutical industry is expected. Experience in Pharmacovigilance would be an advantage, but is not essential. We expect you to be able to work independently and drive your job responsibilities. You work in a structured way and are used to deliver according to targets. The role requires a strong quality orientation including the ability to focus on details and adherence to standards while maintaining a balanced business perspective. Ability to collaborate effectively across departments and organisations with strong commitment to business ethics are essential for the role. You are fluent in both written and spoken English on a professional level. About the department The job is located in a newly established area within Global Safety under IT, Quality & Corporate Development. Global Safety is globally responsible for handling of adverse events, monitoring product safety, customer complaints and potential recalls in Novo Nordisk. The primary responsibility of the Quality department will be to ensure that Global Safety is consistent and meets both external and internal requirements, including legal compliance and customer expectations. We are 13 colleagues with different professional background ensuring support to the Qualified Person for Pharmacovigilance in Novo Nordisk. Since our unit is situated in both Bagsværd and India, you will have the opportunity to work with our Indian colleagues. The application should be written in English. At Novo Nordisk, your skills, dedication and ambition help us change lives for the better. In exchange, we offer you an opportunity to work with extraordinary talent and benefit from a range of possibilities for professional and personal development. Contact For further information, please contact Lasse Bratz Birk on +45 3075 8001. Deadline 8 February 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