stillingsbetegnelse: QA GMP Specialist

jobbeskrivelse:
- compliance - Denmark - Bagsværd Do you want to be the key person in the most inspected area in Novo Nordisk? Are you keen on communicating with regulatory authorities? Are you looking for a career change from your current job as a lead auditor, QA Manager or GMP Specialist? If so, we have a great job opportunity for you as QA GMP Specialist in Sourcing QA. About the department The department is QA for Sourcing Operations and Strategic Sourcing. We are responsible for quality assurance of a large variety of processes within warehousing, purchasing, quality control and supply of raw materials and packaging materials. Sourcing Operations and Strategic Sourcing supply materials to all Novo Nordisk manufacturing sites around the world. We are involved in a high number of inspections from external authorities as QA representatives for these sites. In total, we are 65 dedicated employees divided into 5 closely-knit teams. The job As QA GMP Specialist you will be our local compliance expert. You will be working closely together with specialists and managers from our own organisation and other parts of Novo Nordisk globally. You will manage inspections, including ensuring the challenge and rehearsal of presentations prior to the inspections. You will also ensure clarification and follow-up on any concerns raised by the authorities to obtain a positive outcome of the inspections. You will be responsible for driving strategies for continuous improvement of inspection readiness, and you will drive and support compliance projects within sourcing processes to establish, maintain, and improve compliance in our organisation. You will perform compliance training and also act as GMP expert and consultant for Sourcing Operations, Strategic Sourcing and QA. As QA GMP Specialist you will work in a dynamic and challenging environment where the pressure is high and deadlines are tight. This requires that you are able to make independent decisions, are innovative in order to solve problems, and that you ensure good communication and ongoing dialogue with relevant key stakeholders on a managerial level. Qualifications We expect you to have a Master’s degree or equivalent within pharmaceutical sciences, engineering or a related discipline. You have 10+ years of experience as a lead auditor, QA Manager, GMP Specialist or compliance expert coupled with extensive experience within Quality Management Systems, cGMP, ISO 9001 and ISO 13485. We also expect that you have an excellent understanding of the processes in a pharmaceutical company. You work in a structured and independent manner, you have a strong quality mindset and good communication skills, and you are able to work at all levels of the organisation. As a person, you have a high level of energy, you are able to drive new initiatives, and you want to be in the bull’s eye of a hectic and dynamic environment. You have a positive mindset and you are open towards other people and new ideas. You must be fluent in English, both written and spoken. We offer an exciting job with excellent professional and personal development opportunities where, together with your highly competent colleagues, you will interact with many people both inside and outside of Denmark. At Novo Nordisk, your skills, dedication and ambition help us to change lives. In exchange, we offer you an opportunity to work with an extraordinarily talented workforce and benefits from a range of possibilities for professional and personal development. Contact For further information, please call Karsten Randrup Kragh +45 3079 5913 or Anne Bjerring Olesen +45 3079 2042. Deadline 9 August 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