stillingsbetegnelse:
Senior Facility & Compliance Chemist for Chemical Pilot Plant

jobbeskrivelse:
- Research & Development - Denmark - Bagsværd 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. In this job, 371 million people worldwide depend on you to develop the world’s best drugs. If you find challenges like this exciting and inspiring, you may be our new development scientist within chemical modification and process development of new active pharmaceutical peptides and proteins. About the department The job is located in Novo Nordisk Research & Development area in Bagsværd in the department Chemical Development. In the department you will find 51 highly skilled and motivated colleagues with a “can-do” attitude, who constantly challenge themselves to develop and upscale robust chemical processes in the right quality. Our main responsibility is to develop chemical processes and produce intermediates and API for pre-clinical and clinical studies in the right quality. We do so in close collaboration with the development teams within Novo Nordisk. The job As senior GMP chemist you will be part of the facility and compliance unit within the department. Your tasks will include operating, developing and maintaining our GMP system and increasing the compliance level throughout the department. We expect you to handle review and approval of qualification documentation for instruments, equipment and utilities for manufacturing as well as trend review of equipment, alarms etc. You will be responsible for implementing changes to the GMP system and equipment through change control processes and preparation of validation protocol/reports. You will be handling nonconformance including root cause analysis and implementation of corrective and preventive actions. You will be responsible for the validation of and environmental monitoring in the controlled areas in the facility. All in all you support a high level of compliance in the department. You will participate in cross functional quality activities related to chemical pilot and development activities. Qualifications You hold a master in engineering, chemistry, microbiology or pharmacy optionally combined with a PhD within a related field it. We expect you to have thorough practical work experience with cGMP. You have more than 7 years of industry experience related to quality work within a production, R&D or QA setting. You have experience with qualification of equipment and handling of change control and nonconformance cases. Also you have experience with environmental monitoring and validation of classified areas. You adapt easily to a changing environment and priorities and you have a well-structured approach to your tasks and are capable of maintaining an overview. You keep a positive attitude with focus on delivery on time even under pressure and have a high level of responsibility, flexibility, independence and initiative. On a personal level, you never lose focus, despite changing demands, priorities or tight deadlines. Your personality is characterized by a strong quality mindset, responsibility and enthusiasm. If you can hold on to your good sense of humor at all times, you are the kind of person we are looking for. We are an organization with continuous need to develop new leaders, and therefore leadership ambitions would be an advantage. The everyday language is Danish, so if not already familiar/comfortable with speaking this language, you are expected to be willing to learn the language quickly. 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, pleas

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