Arbejde Qualification - and validation responsible Hovedstaden Novo Nordisk A/S - jobtilbud

GÆLDER
stillingsbetegnelse: Qualification - and validation responsible

jobbeskrivelse:
- Production Support - 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. We are looking for a Qualification- & Validation responsible to join our department and join us in ensuring equipment and facility qualification compliance in our department. You will primarily be responsible for ensuring that ongoing and new equipment qualification projects is carried out in a professional way, with high level of compliance. 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 job You will be responsible for ensuring the department comply with current equipment qualification requirements. Some of the main themes to secure this are setting the right equipment qualification goals and implement the right initiatives to reach these goals in collaboration with the management team. 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. 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. It is required for you to have experience working with qualification in pharmaceutical production or an equipment/facility qualification function in a highly regulated industry. 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, we use our skills, dedication and ambition to help people with diabetes. We offer the chance to be part of a truly global work place, where passion and engagement are met with opportunities for professional and personal development. Contact If any further information is needed please contact Mikkel Stavnsbjerg on +45 3079 6025. Deadline 15 March 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

GÆLDER

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