stillingsbetegnelse:
QA Professisonal - Validation and compliance, CMC QA

jobbeskrivelse:
- Quality - Denmark - Måløv Are you looking for new challenges within QA – development and productions of parenteral bulk product for clinical trials and do you want to make a difference? We are looking for dedicated, professional and enthusiastic new colleagues. About the department In Parenteral Protein Formulation QA we have the responsibility for quality assurance of parenteral formulations and release of investigational medicinal products for clinical trials. We have the QA responsibility of the aseptic pilot production. The CMC development projects include both biopharmaceuticals and diabetes project. The job In close cooperation with your colleagues in QA, you act as a consultant for our aseptic pilot plant. The job consists primarily of facility related QA tasks. You will approve facility related documentation needed for the operation of the aseptic pilot plant e.g. qualification/validation documentation, SOPs and participate as QA in smaller building projects. 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 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 Chemical Engineering, Pharmacy or corresponding qualifications and experience within the pharmaceutical industry. You have thorough knowledge within more of the following areas: GMP, validation/qualification, requirements for aseptic production, and requirements for investigational medicinal products for use in clinical trials. 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 Jens Thorsen at +45 3079 8753. 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