stillingsbetegnelse: Quality Documentation Associate

jobbeskrivelse:
Job Description Biogen Hillerød is looking for a Quality Documentation Associate for the Quality Assurance Documentation group. You will be responsible for processing, reviewing and approving GMP and QA controlled documentation for compliance that supports the development, manufacture and distribution of drug substances, drug products and finished goods produced at Biogen. You will become part of a team of approx. 8 committed colleagues, including FTEs and contractors. JIX1 *LI-DEN2 Location Denmark-Hillerod Job Category Quality Requisition Number 25695BR Qualifications Your main responsibilities: • Facilitate the document change control process from initiation through document effectivity • Provide Quality Assurance representation for Manufacturing Campaigns • Participate in departmental and global documentation projects Professional skills: You have minimum 3 years of experience with documentation systems and record management from the pharmaceutical or another industry. You have good knowledge of Data Management System and Product Lifecycle Management System (eArchival/back up systems). It is an advantage to have experience with a transition process from a paper to an electronic documentation system. You have advanced IT skills and excellent verbal and written skills in English. Knowledge of Good Manufacturing Practices (cGMP) and Quality systems is an advantage as well as experience with project management and Lean/Six Sigma. Personal skills: Personally you have an ability to learn quickly and adapt easily to changes. You have good strategic thinking skills and think “Big Picture”. You are an innovative and flexible person who likes cooperation on different levels. You have strong organization skills and you are a good communicator. You are goal oriented, proactive and good at building relations. Education Bachelor degree in a science, business or technological discipline For more information about the position please contact Maikie Nielsen, Supervisor QA Documentation, tel.+45 77416271 or Eva Op De Beeck, Recruiting Partner, +45 72210860. Expected start date is 1st of October. Your application and CV must be in English. Deadline for application is 31st of July. About Biogen Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia. Founded in 1978, Biogen is the world’s oldest independent biotechnology company. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer’s Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others. With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status. Please be advised that all legitimate correspondence from a Biogen employee will come from " (at) biogen.com" or " (at) biogenidec.com" email accounts.

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Arbejde inden for samfundsøkonomi

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark