stillingsbetegnelse: Qualification - and validation responsible

jobbeskrivelse:
- Production Support - Denmark - Måløv We are looking for a Qualification- & Validation responsible to join our department and join us in ensuring Computer, equipment and facility qualification compliance in our department. You will be part of a highly skilled and experienced team, and you will be given a mandate to set the right qualification strategy in the department. Chemistry, Manufacturing and Control Supply (CMC) is a part of the Research & Development organisation, manufacturing and distributing drug candidates for pre- and clinical trials. We develop and formulate all new protein and peptide processes coming out of our research units in our pilot plants, ensuring that we bring best-in-class treatments to the market. CMC Supply is organised in seven areas of expertise supporting the entire drug development pipeline. Working in CMC Supply, you’ll be part of a team of the best and brightest in your field, where scientific integrity is standard and shared responsibility taken for granted. About the department Clinical Supplies Packaging & Shipping is the department in CMC responsible for the last part of the production before the patients receives the products. We pack and ship products to clinical trials all over the World. The department has expanded a lot the last couple of years and at the moment it consists of approx. 80 employees divided into 4 teams. Going forward the department is expected to experience a lot of changes regarding the equipment and the processes while we still need to deliver products to the trials in the right quality at the right time. The department characteristics are informal tone combined with seriousness on job tasks. The job You will be responsible for ensuring the department comply with current equipment qualification requirements. You will act as main qualification- and validation responsible in CSPS in order to ensure we always reach the right quality level in equipment qualification projects. Preparing and executing qualifications documents (e.g. IQ, OQ and PQ) will also be part of the job. You will act as either project manager or project member in projects with technical aspects. This will include activities to set a standardised level of qualification/validation on all equipment and facilities. Train and support department members in job tasks related to qualifications and validations, are also job tasks in this position. You will also be responsible for presenting relevant documentation in audit situations. Qualifications The job requires a scientific academic background, preferably with a mechanical focus. It is required for you to have some experience working with qualification in pharmaceutical production, but the main prerequisite is the interest in quality insurance by means of through qualification. It would be preferred if you have experience with both equipment and computer qualification/validation. You possess assertiveness and are able to set and communicate goals followed by a structured approach to reach these goals. Collaboration in a broad perspective is a must since both daily dialogue with staff in production and broad stakeholder management is required. Working independent must be a part of your preferred working environment. 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 Mikkel Stavnsbjerg at +45 3079 6025. Deadline 15 April 2015.

Arbejdsgiver Navn: Novo Nordisk A/S

Arbejdsgiver telefonnummer: 44448888

Arbejdsgiver faxnummer: 44442314

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark