stillingsbetegnelse:
Experienced QA for Qualification in Pilot Facilities in CMC

jobbeskrivelse:
- Quality - Denmark - Måløv Are you looking for new challenges within QA – development of tablets for clinical trials and do you want to make a difference? The project portfolio is increasing, and therefore we are looking for a dedicated, professional and enthusiastic new colleague. About the department In CMC Oral Protein Formulation QA we have the responsibility for quality assurance of oral formulations and release of tablets for clinical trials. We have the QA responsibility of the oral formulation development department, the oral pilot production, and building of a new production facility. The job In close cooperation with your 14 colleagues in QA, you act as a QA for our pilot. You contribute to finding solutions for ad hoc questions and challenges within compliance of the facilities. The job is related to qualification/validation of equipment in the pilot 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 such as 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. This means that in QA we work with QA oversight where you proactive, together with your colleagues, will identify areas where our stakeholders’ compliance can be strengthened. You have a risk based approach to the development process and product, and you contribute to find 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 5 years of experience within the pharmaceutical industry. You have thorough knowledge within some of the following areas: GMP, validation/qualification, equipment used in tablet 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 20 July 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