stillingsbetegnelse: Sr Associate I, Manufacturing Compliance

jobbeskrivelse:
Biogen Idec Hillerød is currently expanding its manufacturing capacity of biopharmaceuticals. Therefore we are looking for an experienced and quality conscious Pharmacist, Engineer or similar to drive and support compliance activities in our finished goods manufacturing unit. The Job The position is newly established. As Senior Associate you will provide support to our assembly, label and pack unit as well as our warehouse operations. Your main responsibility will be to improve compliance in the areas ensuring a high level of quality of our finished goods. This involves communication with many other departments and stakeholders both at the manufacturing site in Hillerød and but also with our other sites in Switzerland and USA. Your main tasks will be to • Ensure compliance and high quality standards for Finished goods operation • Lead optimization projects in AL&P and Warehouse operations • Initiate and investigate deviations and ensure that appropriate corrective actions are taken to reduce failures • Ensuring documents are in accordance with GMP as well as external guidelines (EMA&FDA) • Ensure on-time closure of deviations and CAPAs in accordance with defined timelines to support release lead times • Take lead in problem solving of compliance related issues • Act as a close partner to QA to ensure alignment on interpretation of GMP. This team consists of 7 employees and forms part of Assembly, Label & Pack, consisting of 65 Employees. This is an area in strong development with many new production launches and new technologies under implementation. We Offer An exciting and challenging position where you will participate in the launch of several new products over the coming years, where you will develop professionally as well as personally. You will work in an international and highly dynamic environment, including collaboration with international affiliates and external partners. Biogen Idec offers a very competitive and flexible benefit package. Qualifications The ideal candidate has a background as e.g. Pharmacist or Engineer combined with some years’ experience in a GMP regulated finished goods production environment. Moreover we are looking for an analytic, robust person able to both create an overview and knowing the details including regulations and demands from the relevant authorities. Important skills for this role are: • Knowledge of GMP, regulatory demands and experience with compliance support in a production environment is needed • Ability to create, establish and maintain a high compliance level by analyzing data • Strong English skills • A strong drive and motivation for implementing different optimization projects independently in line with LEAN • Ability to work independently, take initiative and ownership of your work • Coordinate and communicate with cross functional groups Education The ideal candidate has a background as e.g. Pharmacist or Engineer

Arbejdsgiver Navn: BIOGEN IDEC (DENMARK) NEW MANUFACTURING ApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Farmaceutarbejde

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark