stillingsbetegnelse: Validation Expert

jobbeskrivelse:
Production Support Denmark - Hillerød Would you like to leave your mark on the validation strategy in Prefilled Device Assembly? Become our validation expert in Device Manufacturing Development. Anticipate a strategic role where you will secure that all major prefilled assembly lines in PS will deliver a quality product to the patients. About the department You will join a dedicated and highly competent Process team and be at the crossroad between Device R&D, Quality and Production. Our field of responsibility on the prefilled assembly processes covers the validation of the lines, the operation procedures to operate them, the expertise of the products and the continuous improvement of the lines and technologies. The job Your objective is to manage our validation strategy and develop and consolidate the fundamental and global validation documents (eg. URS, pFMEA and technical rationales) we are responsible for. As validation professional you will ensure the validation strategy and all standardised validation documentation is in compliance with the internal and external requirements. You will be joining the Process Groups in your field of responsibility and speak the voice of DMD in the networks in DFP, DMS and at PS level. Specifically, you will manage the existing standard validation documents and lead or contribute to their continuous improvement. You will evolve in a complex environment and be responsible of our 2 major products, FlexPen and FlexTouch and 3 assembly processes. You will develop the standard assembly validation with a Lean thinking and with respect for the voice of the process and of the customer and ensure their anchoring in the sites. You will maintain the documents and ensure timely updates of the documents as the quality documentation and equipment evolve. You will also participate in the validation activities of the new equipment both at our vendors and at the production sites. Finally you will share your expertise and deliver adequate training on validation to our internal and external stakeholders. You mission will lead you to the shopfloor around the world at our production sites and to the assembly lines suppliers. You should anticipate up to 20 yearly travel days to various sites, among others, in Brazil, US, France and Switzerland. Qualifications You have combined your Master’s degree in pharmaceutical or similar with 5 years of experience in quality or process support. You have a proven track record in GMP and risk analysis expertise and have successfully worked with validation. Success in this job calls for structured person balancing theory with a pragmatic approach. You can just as well conceptualise the validation strategy and master the details at the level of the components on the line and must be able to explain it all in an intelligible way to yours stakeholders and colleagues. At Novo Nordisk, you will be part of a company respected equally for its financial results and its business ethics. Across geographical, cultural and professional communities we develop and deliver innovative medicines Contact For further information, please contact Yannick Segonne at +45 3079 2318. Deadline 2 July 2014

Arbejdsgiver Navn: NOVO NORDISK A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark