stillingsbetegnelse: QA Academic for Quality Assurance of New Products

jobbeskrivelse:
Quality Denmark - Bagsværd Do you want to unfold your profound QA knowledge and your huge appetite for creating results in a pharmaceutical production environment? If so, please apply for the position as QA Academic in a job that includes many different clinical stages of the product development. About the department In Chemistry, Manufacturing & Control (CMC) API QA we assure that each and every Active Pharmaceutical Ingredient (API) activity in our development and support projects live up to the cGMP requirements. The development portfolio is expanding and thus we seeking a new colleague to help us support the growth. We are 32 colleagues in three teams. You will join the upstream team and have 10 dedicated colleagues. Our mission is to assure that our API manufacturing processes (cell banks, cell cultivation and stem cells) meet the internal and external requirements. Furthermore we’re responsible for release of API for all of Novo Nordisk’s clinical trials. The production facilities and the development laboratories are located in Bagsværd and Hillerød, and you will move between the different locations and the QA office on a day-to-day basis. The job You assure best-in-class quality of our production areas regarding validation and qualification of the equipment, environment and utilities. Document approval in connection with qualification, cleaning, maintenance and improvement of the quality system (SOP’s) will constitute some of your daily tasks. In addition, you may participate in investment projects, rebuilding of existing facilities and building of new facilities. In close cooperation with your colleagues you identify and contribute to the strengthening our stakeholders’ compliance level. We operate in a LEAN-dominated environment, and you will have the opportunity to contribute with ideas for improvements and drive the subsequent implementation as well. Working within QA will definitely challenge your professional and individual skills, and you will find that your tasks cover many different clinical stages of the product development. Qualifications You hold a Master’s degree in Pharmacy, Chemical Engineering or possess equivalent qualifications besides a strong quality mind-set. You have at least 2 years’ experience with GMP, equipment/facilitation, qualification and cleaning from the production or the QA area. As we operate in a national as well as an international environment, you must speak and write Danish and English fluently. You are ambitious and determined on creating world-class results and ensure quality of the highest order. Moreover, you thrive in a role where you use your knowledge and bring your arguments and negotiation skills into play. You are able to adapt but also challenge our way of working so that we constantly improve our methods and processes. 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 Lisbeth Voetmann on + 45 3075 0530 or Peter Søtofte Elten on + 45 3079 8453. Deadline 17 June 2014.

Arbejdsgiver Navn: NOVO NORDISK A/S

Arbejdsgiver telefonnummer: 44448888

Job kort beskrivelse: Ingeniørarbejde inden for mekaniske systemer

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark