stillingsbetegnelse: QA Professional Validation/Qualification in CMC

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. Are you looking for new challenges and do you want to make a difference within QA for development of tablets for clinical trials? Our stakeholders are expanding and creating a new department responsible for development and manufacturing of oral protein products for clinical trials. This department covers a broad and exciting range of process technologies for solid dosage forms. Therefore, we are looking for a dedicated, professional and enthusiastic new QA colleague. About the department In CMC OPF QA, we are 12 QA professionals and technicians. We have the responsibility for quality assurance of oral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility of the existing oral pilot production and facility, and furthermore we have the QA responsibility for construction of the new facility to support phase III production. The Job In close cooperation with your colleagues in QA, you act as QA primarily for this new department. You will contribute with the establishment of the quality system for the department and you will be involved in approving qualification documentation for the new facility. You will also contribute to finding solutions for ad hoc questions and challenges within compliance of the facilities. You will assure that the documentation for implementation and maintenance of equipment is compliant with internal and external requirements. Furthermore, you will approve facility related documentation needed for the operation of the plant eg. change request, non-conformities, SOP’s, environmental monitoring and utilities. 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 together with your colleagues will proactively identify areas where our stakeholders’ compliance can be strengthened. You have a risk based approach to the development process and products, and you contribute to finding the right balance between patient safety, compliance to requirements and effective business conduct. Qualifications Ideally, you have a master in Pharmacy, Chemical Eng. or corresponding qualifications and at least 1-2 years of experience within the pharmaceutical industry. You have thorough knowledge within more of the following areas: GMP, validation/qualification, equipment used in tablet and/or aseptic production. 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. 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 Janne Lavritsen at +45 3075 7333. Deadline 15 December 2014.

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