stillingsbetegnelse: Sr. QA Professional

jobbeskrivelse:
- Quality - 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. Highly professional and well implemented IT quality assurance is key to support our stakeholders in CMC Supply. We are facing an increase of projects and are expanding and thus we are looking for a new colleague in CMC QA. Are you looking for new challenges within QA and do you want to make a difference within IT quality assurance for our stakeholders? Then you might be our new colleague. . About the department In Parenteral Protein Formulation QA we have the responsibility for quality assurance of parenteral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility of the aseptic pilot production and development laboratories. The job In close cooperation with your colleagues in QA, you handle quality assurance of the stakeholders IT systems and participate in IT projects across CMC Supply. The job covers activities ranging from advising colleagues, participating in small or larger IT projects in pilot plants and laboratories. These projects typically include approval of change requests, design, qualification, validation, maintenance and approval of procedures. Thus you will be involved in many varied and challenging tasks and engage with multiple stakeholders. You will also be responsible for assuring that the documentation is compliant with internal and external requirements. CMC Supply’s continuing high level of audit and inspection readiness is on top on your agenda. In CMC Supply QA we work with QA oversight where you proactive together with your colleagues will identify areas where our stakeholders’ compliance can be strengthened. You contribute to find the right balance between patient safety, compliance to requirements and effective business conduct. Qualifications You should have a solid understanding of European and US regulatory requirements to computer validation and should be able to link computer systems to production processes. The position requires significant insight into key IT processes, e.g. requirements, quality management, project management, change and configuration management, IT security, risk management, testing. You should also demonstrate solid insight into business processes, e.g. manufacturing in GMP environment. Ideally, you have a master in engineering or corresponding qualifications and at least 3-5 years of experience within the pharmaceutical industry. You enjoy working in a dynamic environment, where teamwork is at the top of the agenda. Also, you are quite adaptable and challenge our way of doing things, so that we will get even better. You focus on results and quality and contribute to the right level of compliance. You are able to present complex matters in a clear and precise way. Working at Novo Nordisk 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 Jens Thorsen at +45 3079 8753. Deadline 5 January 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